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Clinical Research Trials
(Updated March 2007)

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Sponsors
Listed below are the abbreviations for the national cooperative agencies and sponsors that you will see in the clinical trial descriptions.

  • ACOSOG - American College of Surgeons Oncology Group
  • ECOG - Eastern Cooperative Oncology Group
  • NCI - National Cancer Institute
  • NSABP - National Surgical Adjuvant Breast Project
  • RTOG - Radiation Therapy Oncology Group
  • SWOG - Southwest Oncology Group
Brain/Central Nervous System Protocols


RTOG
98-13
A Phase III (Phase I Closed) Randomized Study of Radiation Therapy and Temozolomide versus Radiation Therapy and BCNU for Anaplastic Astrocytoma and Mixed Anaplastic Oligoastrocytoma (Astrocytoma Dominant)

Click here for a printable description of this Clinical Research Trial.
 
RTOG
0227
Phase I/II Study of Pre-Irradiation Chemotherapy with Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma

Click here for a printable description of this Clinical Research Trial.
 
RTOG
0424
A Phase Ii Study Of A Temozolomide-Based Chemoradiotherapy Regimen For High Risk Low-Grade Gliomas

Click here for a printable description of this Clinical Research Trial.


Breast Protocols

E1103 A Phase II Trial of Capecitabine in Combination with the Farnesyltransferase Inhibitor, R115777 (Tipifarnib, Zarnestra) in Patients with Metastatic Breast Cancer

Click here for a printable description of this Clinical Research Trial.
 
ECOG
E2104
Phase II Feasibility Trial Incorporating Bevacizumab into Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Patients with Lymph Node Positive Breast Cancer

Click here for a printable description of this Clinical Research Trial.
 
ECOG
E4101
A Randomized Phase II Trial of Combination Anastrozole (NSC#719344) plus ZD 1839 (Iressa, NSC#715055, IND#61187) and of Combination Fulvestrant (NSC#71926) plus ZD 1839 in the Treatment of Postmenopausal Women with Hormone Receptor-Positive Metastatic Breast Cancer

This protocol addresses breast cancer in women who had hormone positive tumor. Normally these patients are treated with Tamoxifen as an adjunct. The patient population for this study is women who have had a relapse after Tamoxifen and who are postmenopausal. Ordinarily, these women are treated with an aromatase inhibitor such as Anastrozole or Letrozole or Fulvestrant.

The purpose of this study is to use a molecular agent known as Iressa (ZD1839) in combination with Anastrozole or in combination with Fulvestrant. The use of Anastrozole or Fulvestrant is FDA approved. Iressa is a new agent that has been approved for some forms of lung cancer. In this study, we are looking at the benefit of Iressa combined with other hormonal agents. Anastrozole and Fulvestrant will be obtained from the usual sources but Iressa will be supplied by the National Cancer Institute.
 
NSABP
B-35
A Clinical Trial Comparing Anastrozole with Tamoxifen in Postmenopausal Patients with Ductal Carcinoma In Situ (DCIS) Undergoing Lumpectomy with Radiation Therapy

Ductal carcinoma in situ is a non-invasive breast cancer that is usually treated by lumpectomy and radiation therapy. Previous NSABP programs have shown that Tamoxifen is of additional benefit by lessening the instances of second malignancies (both ductal carcinoma in situ and invasive cancer) to the affected breast as well as to the contralateral breast. Recent data with an aromatase inhibitor, Anastrozole, given to women who had invasive cancer shows that aromatase inhibitor is equal to the effectiveness of Tamoxifen as postoperative therapy. The purpose of this study is to apply the same logic to ductal carcinoma in situ and see if aromatase inhibitor similarly lessens the chances of second malignancies.

Please be aware that both drugs are FDA approved and are widely utilized in breast cancer treatment. In addition to Tamoxifen's benefits in preventing breast cancer, it is good for bone support; however, Tamoxifen is associated with venous thromboembolic disease, endometrial carcinoma and hot flashes. Anastrozole has no benefit in bony support but is not associated with carcinoma of the endometrium. The purpose of this study is to look at the benefits and risks of these agents.

Please also note that invasive breast cancer is usually evaluated for estrogen and progesterone activity. Retrospective data on ductal carcinoma in situ shows that Tamoxifen is only beneficial in those tumors that are estrogen receptor positive. Consequently, women enrolled in this study must have tumors assessed for estrogen receptor. Lastly, please note that postmenopausal women are included in this program because the effect of an aromatase inhibitor is only possible in women who have no functioning.
 
NSABP
B-36
A Clinical Trial of Adjuvant Therapy Comparing Six Cyclesof 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC), With or Without Celecoxib, in Patients With Node-Negative Breast Cancer
 
NSABP
B-37
A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-regional Relapse of Breast Cancer

Click here for a printable description of this Clinical Research Trial.
 
NSABP
B-38
A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens in Women with Node-Positive Breast Cancer: Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed by DD Paclitaxel (DD AC P); DD AC Followed by DD Paclitaxel Plus Gemcitabine (DD AC PG)

Click here for a printable description of this Clinical Research Trial.
 
NSABP
B-39
RTOG
0413
A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer

Click here for a printable description of this Clinical Research Trial.
 
S0230 Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarial Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
 
FB-AX-003 A Phase 2 Study of Neoadjuvant Chemotherapy with Sequential Weekly Nanoparticle Albumin Bound Paclitaxel (Abraxane) Followed by 5-Fluorouracil, Epirubicin, Cyclophosphamide (FEC) in Locally Advanced Breast Cancer

Click here for a printable description of this Clinical Research Trial.



Breast Protocols - Pharmaceutical

AVF3693g A Phase III, Multicenter, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination with Chemotherapy Regimens in Subjects with Previously Treated Metastatic Breast Cancer.

Click here for a printable description of this Clinical Research Trial.
 
AVF3694g A Multicenter, Phase III, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination with Chemotherapy Regimens in Subjects with Previously Untreated Metastatic Breast Cancer

Click here for a printable description of this Clinical Research Trial.
 
CRN-004 AVENTIS: A Phase II Trial of Neoadjuvant Docetaxel with Carboplatin and Capecitabine in Locally Advanced Breast Cancer (GIA# 11217)

This protocol is directed at the use of chemotherapy prior to the resection of breast cancer (neoadjuvant treatment). In previous protocols neoadjuvant therapy has been provided with Adriamycin and Cyclophosphamide (AC) as well as AC followed by Taxol in other studies and, still other combinations among some of the study groups. This protocol attempts to look at three active drugs for breast cancer that are significantly different from AC. Following surgery, patients will be receiving standard AC treatment, the most frequently combination in postoperative adjuvant chemotherapy studies.

The use of preoperative adjuvant chemotherapy is directed at shrinkage of tumor size in order to decrease the extent of tumor and subsequent resection. In NSABP studies in which AC was used with or without Taxol, approximately 80% of the tumors responded by decreasing at least half of its size or more so. In earlier studies, approximately 15% of the patients had no histologic diagnosis of cancer at the time of resection. In more recent studies, when Taxol was added to AC the percentages have increased in response rate both clinically and histologically.

In the current study, Docetaxel, Carboplatin, and Capecitabine are being investigated as neoadjuvant treatment. These drugs are highly effective and all FDA approved for breast cancer. The goal of the program is to recruit women who have measurable disease and provide them with four cycles of this treatment (4 monthly cycles of this treatment prior to surgery). In those patients in whom there is a clinical response or stable disease during neoadjuvant therapy, treatment will be completed followed by surgery, following which four additional cycles of AC are offered. If at any time after the initiation of neoadjuvant therapy the disease progresses, then patients can be removed from the study and be treated traditionally with surgery. Please note that Capecitabine is an oral agent provided for two weeks out of every month and Docetaxel and Carboplatin are intravenous agents provided on Days 1, 8 and 15 of 28 day cycle.



ECOG Stem Cell/Transplant Protocols

E-2993 Phase III Randomized Trial of Autologous & Allogeneic BMT vs. Intensive Conventional Chemotherapy in Acute Lymphoblastic Leukemia of First Remission.
 
S9704 A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy (with Possible Late Autologous Stem Cell Transplant) for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate and High Risk International Classification Prognostic Groups
 
 
E1402
A Phase II Study of Reduced Intensity (Nonmyeloablative) Allogeneic Bone Marrow Transplantation for the Treatment of Relapsed Non-Hodgkin's and Hodgkin's Lymphoma

Click here for a printable description of this Clinical Research Trial.
 
E1900 A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification and Gemtuzumab-Ozogamicin consolidation Therapy Prior to Autologous Stem Cell Transplantation
 
E2499 Randomized Phase III Trial of Rituximab (NSC #687451) and Autologous Stem Cell Transplantation for B Cell Diffuse Large Cell Lymphoma


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Gastrointestinal Protocols

E4298 Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases: A Phase II Multi-Center Trial - (Partial suspension for Hepatocellular CA 6/26/00)(Neuroendocrine suspended 3/5/01)
 
 
E5202
A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers

Click here for a printable description of this Clinical Research Trial.

 
 
E5203
A Phase II Study to Evaluate Overall Response Rate of BAY 43-9006 (Sorafenib) Combined with Docetaxel and Cisplatin in the Treatment of Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma.

Click here for a printable description of this Clinical Research Trial.

 
Z9001A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary GastroIntestinal Stromal Tumor (GIST)

Gastrointestinal stromal tumors are sarcoma of the stomach that expresses c-kit oncogene, a protein that is responsible for the enzyme associated with malignancy. Importantly, this tumor was highly aggressive and lethal in the past but is totally reversible and correctable with a molecular STI571 (Gleevec) that specifically acts on c-kit oncogene. STI571 has been FDA approved and is currently available. The purpose of this study is to take patients with resected GIST and randomize them into placebo or STI571 in order to determine whether treatment has any improvement on overall survival. Patients will be provided medication in double-blinded fashion. This protocol differs from Z9000 in that the previous study provided STI571 to all patients following resection because their malignancy was of a higher grade and more likely to recur.
 
E8200 A Phase II Trial of Irinotecan/Docetaxel for Advanced Pancreatic Cancer with Randomization Between Irinotecan/Docetaxel and Irinotecan/Docetaxel Plus C225, A Monoclonal Antibody to the Epidermal Growth Factor Receptor (EGF-R)

E8200, is A Phase II Trial of Irinotecan/Docetaxel for Advanced Pancreatic Cancer with Randomization Between Irinotecan/Docetaxel and Irinotecan/Docetaxel Plus C225, a Monoclonal Antibody to the Epidermal Growth Factor Receptor (EGF-R). The study treatment is directed at an investigation of the effectiveness of monoclonal antibody C225 in addition to standard chemotherapy (Docetaxel and Irinotecan). The type of carcinoma being examined is metastatic pancreatic carcinoma.

Carcinoma of the pancreas is usually an incurable malignancy that occurs whether it is wide-spread or localized initially. When it is treated with surgical resection it is found localized at its initial presentation. When it is non-resected initially it is often treated with radiation and chemotherapy. When it is metastatic initially or when it returns after initial therapy, it is usually treated with chemotherapy. Standard chemotherapy drugs have been Gemcitabine and 5-Fluorouracil. Previous ECOG study combination of Gemcitabine and 5-Fluorouracil was evaluated and a high incidence of thromboembolic disease was found. Additionally, this combination ( 5-FU and Gemcitabine) was also low in effectiveness on the tumor.

A number of small trials have used Docetaxel and Irinotecan because these agents have different mechanisms of action and different toxicity profiles. In this research study, all the patients will receive this combination of chemotherapy. In addition, half of the patients will be randomized to receive a monoclonal antibody directed against epidermal growth factor receptor (EGF-R). This monoclonal antibody is referred to as C225 or Cetuximab. EGF-R is over expressed in many pancreatic carcinoma patients. The purpose of this study is to see if the monoclonal antibody added to chemotherapy has any greater effectiveness as compared with the chemotherapy alone. In addition, toxicity profile will be assessed.

Please note that C225 has recently been approved by the FDA but not for pancreatic carcinoma; hence it will be provided.
 
NSABP
P-3
Celecoxib Polyp Prevention Trial in Participants with Resected Stage I Colon Cancer (Suspended)

Click here for a printable description of this Clinical Research Trial.
 
RTOG
0529
A Phase II Evaluation of Dose-Painted IMRT in Combination with 5-Fluorouracil and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal

Click here for a printable description of this Clinical Research Trial.


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Gastrointestinal Protocols - Pharmaceutical

 
ROCHE
ML18491
A Randomized Study of Intermittent Capecitabine in Combination with Oxaliplatin (XELOX Q3W) and Bevacizumab v. Intermittent Capecitabine in Combination with Oxaliplatin (XELOX Q2W) and Bevacizumab as First-Line Treatment for Patients with Metastatic Colorectal Cancer

Click here for a printable description of this Clinical Research Trial.



Genitourinary Protocols

 
S-9346 Intermittent Androgen Deprivation in Pts with Stage D2 Prostate Cancer
 
E1804 Phase II Trial of Sorafenib (BAY 43-9006) (IND 69896: NSC 724772) in Patients with Advanced Urothelial Cancer

Click here for a printable description of this Clinical Research Trial.

 
E6800 A Phase II Trial Evaluating Astrasentan in Patients with Advanced Renal Cell Carcinoma (8/13/03 No prior immunotherapy cohort only suspended)
 
ECOG
E3803
A Phase II Study of a Weekly Schedule of BMS-247550 for Patients with Hormone Refractory Prostate Cancer

Click here for a printable description of this Clinical Research Trial.
 
ECOG
E2803
A Phase II Trial of Paclitaxel Plus Carboplatin in Patients with Metastatic or Locally Advanced Collecting Duct Renal Cell Cancer

Click here for a printable description of this Clinical Research Trial.
 
 
E5803
A Phase II Trial of GW572016 in Patients with Recurrent Prostate Cancer as Evident by a Rising PSA

Click here for a printable description of this Clinical Research Trial.

 
E8802 A Phase Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma with Sarcomatoid Features

Renal cell carcinoma is a malignancy that begins in the kidney and is treated surgically. When the disease is not confined, it most often spreads to bones, lung, contralateral kidney or to other sites. Most of the chemotherapy that is used is not effective; at the current time, immune therapy is the treatment of choice.

The sarcomatoid variant of renal cell carcinoma has histologic (microscopic) features that resemble sarcomas, tumors of connective tissues. Some of these tumors have been shown to have an extremely high rate of metastases with a survival as short as four months, if untreated. One group of investigators took advantage of the high growth rate of this malignancy and used combination chemotherapy showing approximately 25% rate of a complete response. In view of this, the Eastern Cooperative Oncology Group is setting out to explore two drugs (Gemcitabine and 5-Fluorouracil) to measure its effectiveness as well as potential toxicity in sarcomatoid renal cell carcinoma.
 
RTOG
0233
A Phase II Randomized Trial For Patients With Muscle-Invading Bladder Cancer Evaluating Transurethral Surgery And BID Irradiation Plus Either Paclitaxel And Cisplatin Or 5-Fluorouracil And Cisplatin Followed By Selective Bladder Preservation And Gemcitabine/Paclitaxel/Cisplatin Adjuvant Chemotherapy

Click here for a printable description of this Clinical Research Trial.


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Gynecological Protocols

RTOG
C-0116
A Two-Part Phase I/II Study Of Extended Field External Irradiation And Intracavitary Brachytherapy Combined With Chemotherapy (Weekly Cisplatin-Arm 1) And Amifostine (Weekly Cisplatin And Amifostine-Arm 2) In Carcinoma Of The Cervix With Positive Para-Aortic Or High Common Iliac Lymph Nodes

Click here for a printable description of this Clinical Research Trial.


Gynecological Protocols - Pharmaceutical

All clinical trials in this category are closed at this time.

Head & Neck Protocols

 
E1302 Phase III Randomized, Placebo Controlled, Trial of Docetaxel versus Docetaxel Plus ZD1839 (Iressa, Gefitinib) in Performance Status 2 or Previously Treated Patients with Recurrent or Metastatic Head and Neck Cancer

Click here for a printable description of this Clinical Research Trial.
 
E1304 Phase II Two Arm Trial of the Proteasome Inhibitor, PS-341 (VELCADE™) in Combination with Irinotecan or PS-341 Alone Followed by the Addition of Irinotecan at Time of Progression in Patients with Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Click here for a printable description of this Clinical Research Trial.
 
E2303 Phase II Evaluation of Cetuximab (C225) Combined with Induction Paclitaxel and Carboplatin Followed by C225, Paclitaxel, Carboplatin, and Radiation for Stage III/IV Operable Squamous Cancer of the Head and Neck

Click here for a printable description of this Clinical Research Trial.
 
E3303 Phase II Study of C225 (Erbitux or Cetuximab) in Combination with Cisplatin and Definitive Radiation in Unresectable Stage IV Squamous Cell Carcinoma of the Head and Neck

Click here for a printable description of this Clinical Research Trial.
 
E1F02 A Phase II Study of Systemic High-Dose Methotrexate for the Treatment of Glioblastoma Multiforme in Newly Diagnosed Patients with Measurable Disease

Click here for a printable description of this Clinical Research Trial.
 
RTOG
0522
A RANDOMIZED PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) [FOLLOWED BY SURGERY FOR SELECTED PATIENT] FOR STAGE III AND IV HEAD AND NECK CARCINOMAS

Click here for a printable description of this Clinical Research Trial.
 
RTOG
0615
A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV)[NSC 708865; IND 7921] for Locally or Regionally Advanced Nasopharyngeal Cancer

Click here for a printable description of this Clinical Research Trial.


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Hematology Protocols

E1402 A Phase II Study of Reduced Intensity (Nonmyeloablative) Allogeneic Bone Marrow Transplantation for the Treatment of Relapsed Non-Hodgkin's and Hodgkin's Lymphoma

Click here for a printable description of this Clinical Research Trial.
 
E1404 A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin's Lymphoma

Click here for a printable description of this Clinical Research Trial.
 
E-2993 Phase III Randomized Trial of Autologous & Allogeneic BMT Vs. Intensive Conventional Chemotherapy in Acute Lymphoblastic Leukemia of First Remission. (StemCell Proto)
 
U1099 Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma
SUSPENDED 7/12/02
 
E2496 Randomized Phase III Trial of ABVD vs. Stanford V + Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease with 0-2 Risk Factors
 
E5998 A Phase II Study of Initial Treatment with Methotrexate in Large Granular Lymphocytic (LGL) Leukemia
 
S0325 A combined study with the Southwestern Oncology Group, A Phase IIb Study of Molecular Responses to Imatinib at Standard or Increased Doses for Previously Untreated Patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase

Click here for a printable description of this Clinical Research Trial.
 
S9704 A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy (with Possible Late Autologous Stem Cell Transplant) for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate and High Risk International Classification Prognostic Groups (Stem Cell Protocol)
 
E1900 A Phase III Trial in Adult Acute Lyeloid Leukemia: Daunorubicin Dose-Intensification and Gemtuxumab-Ozogamicin Consolidation Therapy Prior to Autologous Stem Cell Transplantation (STEM CELL)

The treatment of adult acute myelogenous leukemia is reasonably standard around the world. Patients receive a combination of cytosine arabinoside (ARA-C) and an anthrocycline (Daunorubicin). Once a remission occurs, a variety of treatment is used to try and maintain remission. These treatments are variable without any proven benefits at this time. In some instances, patients receive a bone marrow transplantation from an allogeneic donor. In other situations, patients receive high doses of cytosine arabinoside. In most instances, where an allogeneic bone transplant donor is available, patients receive the transplantation. However, in many instances, patients are unable to receive a transplantation because of their health or age. Consequently, high-dose cytosine arabinoside is frequently utilized to attempt to re-enforce the remission of acute leukemia.

Despite consolidation therapy of acute leukemia, relapses still occur. In this study, patients who go into remission and who have no allogeneic donor will receive high doses of cytosine arabinoside. In addition, half of the patients will also receive Gemtuzumab (Mylotarg), a monoclonal antibody that is approved for relapsed myelogenous leukemia. Gemtuzumab is a humanized monoclonal antibody directed against CD33. It is linked to a toxin calicheamicin. This agent is effective and is commonly used in acute myelogenous leukemia on relapse especially in the elderly. Finally, all patients in this protocol will undergo autologous stem cell transplantation from their harvested peripheral blood cells once they are in remission.
 
E2402 A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma

Click here for a printable description of this Clinical Research Trial.
 
E2499 Randomized Phase III Trial of Rituximab (NSC #687451) and Autologous Stem Cell Transplantation for B Cell Diffuse Large Cell Lymphoma (STEM CELL)
 
E2903 Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Campath-1H For Previously Treated Relapsed or Refractory Patients With Chronic Lymphocytic Leukemia

Click here for a printable description of this Clinical Research Trial.
 
E3903 Ancillary Laboratory Protocol for Collecting Diagnostic Material on Patients Considered for ECOG Treatment

Click here for a printable description of this Clinical Research Trial.
 
E4402 Randomized, Phase III Trial Comparing Two Different Rituximab Dosing Regimens for Patients with Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
 
SPD
758-216
Structural Genomix: An Open-Label, Single-Arm, Multi-Center, Phase II Study of Troxatyl (troxacitabine) Administered by Continuous Infusion in Patients with Acute Myeloid Leukemia (AML) in Second Salvage

Click here for a printable description of this Clinical Research Trial.
 


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Hematology Protocols - Pharmaceutical

 
PIX301 CTI: Pixantrone (BBR2778) versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients with Relapsed Aggressive Non-Hodgkin’s Lymphoma: A Randomized, Controlled, Phase III Comparative Trial

Click here for a printable description of this Clinical Research Trial.
 
5312-01 SYNTA: A Phase I Trial of STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematological Malignancies

Click here for a printable description of this Clinical Research Trial.


Lung

E1B03 Pemetrexed Plus Gemcitabine or Carboplatin in Patients with Advanced Malignant Mesothelioma: A Randomized Phase II Trial is active for inclusion of new patients

Click here for a printable description of this Clinical Research Trial.
 
E2501 A Double Blind Phase II Study of BAY 43-9006 in Patients with Non-Small Cell Lung Cancer Who Have Failed at Least Two Prior Chemotherapy Regimens

Click here for a printable description of this Clinical Research Trial.
 
E3501 A Phase II Study of Cisplatin plus Etoposide (PE) plus Bevacizumab (BSC #704865) for Previously Untreated Extensive Stage Small Cell Lung Cancer

Click here for a printable description of this Clinical Research Trial.
 
E3598 A Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients with Stage III NSCLC
 
E5597 Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer
 
S0220 A Phase II Trial of Induction Chemoradiotherapy with Cisplatin-Etoposide Followed by Surgical Resection, Followed by Docetaxel for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)

Occasionally, there are lung cancers that appear at the top most portion of the lung that result in a number of symptoms related to direct extension to the tissues just above the margins of the lung. Many times, the subclavian artery is affected and pain may result in the shoulder or arm because of affecting the corresponding nerve roots. In addition, some of the neurologic tract that originates in the neck but returns to the side of the face and to the orbit are affected as well. This type of tumor is known as Pancoast and accounts for only 3% of all lung malignancies.

These patients are usually not surgically correctable because of the extension of disease outside of the lung. The purpose of this study is to register all eligible patients and provide them with Cisplatin, Etoposide and radiation therapy for a period of five weeks, following which they will be reassessed. In those patients in whom there is a complete response, partial response or stable disease, they may be re-registered to undergo a surgical resection. In those patients who are medically unfit for the surgical resection or they refuse such a procedure, then they would resume radiation therapy. In either instance, when surgery is accomplished or radiation therapy is completed, all patients will continue on Taxane therapy (Taxotere). For those patients who undergo the initial chemotherapy and radiation therapy in whom there is progression of disease, they will be taken off study.

Please note that the drugs that are used in this study are all FDA approved.
 
RTOG
0214
A Phase III Comparison of Prophylactic Cranial Irradiation versus Observation in Patients with Locally Advanced Non-Small Cell Lung Cancer

Click here for a printable description of this Clinical Research Trial.
 
ACRIN
6668
RTOG
0235
Positron Emission Tomography Pre- and Post-treatment Assessment for Locally Advanced Non-Small Cell Lung Carcinoma

Click here for a printable description of this Clinical Research Trial.


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Lung Protocols - Pharmaceutical

All clinical trials in this category are closed at this time.

Melanoma/Sarcoma Protocols

CA184022 A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients with Previously Treated Unresectable Stage III or IV Melanoma

Click here for a printable description of this Clinical Research Trial.

 
E1697 Randomized Study of Four Weeks High Dose IFN-a2b in Stage II-A Melanoma
 
E4697 A Randomized, Placebo-controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients with 'No Evidence of Disease' after Complete Surgical Resection of 'Locally Advanced' and/or Stage IV Melanoma
S9431 Cytogenetic, Molecular, and Cellular Biology Studies in Metastatic Melanoma Patients
 
S0008 Phase III Trial of High Dose Interferon Alpha-2b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients With High Risk Melanoma


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Miscellaneous Protocols

E1C99 Phase II Study of Carboplatin plus Paclitaxel Treatment of Advanced Thymoma or Thymic Carcinoma
 
ECOG
E1Y03
Master Protocol For Pharmacogenetic and Genomic Studies

Click here for a printable description of this Clinical Research Trial.
 
E4Z02 Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of Levocarnitine for Fatigue in Patients with Cancer.

Click here for a printable description of this Clinical Research Trial.
 
S0000A Selenium and Vitamin E. Cancer Prevention Trial (PREADVICE)
 
Registry Quadramet™ National Bone Pain Management Registry

Click here for a printable description of this Clinical Research Trial.


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