BREAST CANCER

Does Prolonged Adjuvant Hormonal Therapy Improve Disease-free Survival in Postmenopausal Women With ER+ and/or PgR+ Breast Cancer?
A phase III study to determine if prolonged adjuvant hormonal therapy with Letrozole will improve disease-free survival in postmenopausal women with ER+ and/or PgR+ tumors who have completed five years of hormonal therapy and either five years of an aromatase inhibitor or up to three years of tamoxifen followed by an aromatase inhibitor. (B42)

TC (Docetaxel/Cyclophosphamide) versus TAC versus TC+Bevacizumab in Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer Patients
This study will compare the use of standard chemotherapy +/- Bevacizumab, a VEGF inhibitor, to treat women with node-positive or high-risk node-negative, HER2-negative breast cancer. (07-132)

Trial for HER2+ Metastatic Breast Cancer with Abraxane and Lapatinib
This is an open-label, single-arm, multi-center, phase II study to determine the activity of nabpaclitaxel plus Lapatinib in the first and second-line setting in women with ErbB2 over-expressing metastatic breast cancer. Study participants will receive Nab-Paclitaxel intravenously on day 1, 8, 15 every 28 days plus Lapatinib daily on a continuous basis. (LPT 111111)

Treatment for Hormone Receptor Positive, HER2- Negative Post-Menopausal Metastatic Breast Cancer
This study is first/second line treatment for metastatic breast cancer. On Arm 1, patients receive Letrozole 2.5mg by mouth every day plus Dasatinib 100mg by mouth every day, arm 1B if Dasatinib dropped due to toxicity. On Arm 2, patients receive single-agent Letrozole 2.5mg by mouth every day. Patients who progress on Arm 2 will move to Arm 2B, which adds Dasatinib to Letrozole. (06-185)

Fulvestrant w/ or without Dasatinib in Men and Postmenopausal Women who have Hormone Receptor-Positive Advanced Breast Cancer Previously Treated with an Aromatase Inhibitor
Phase II, randomized trial of Fulvestrant is a pure estrogen receptor antagonist that degrades the estrogen receptor. Dasatinib is a multi-tyrosine kinase inhibitor including the Src family kinases. Src is involved in both primary tumor growth and especially migration, invasion and metastasis. Dastinib has also shown to decrease bone resorption in clinical trials (06-030)

Gemcitabine/Carboplatin, with or without BSI-201, in Patients with ER, PR, and HER2-Negative Metastatic Breast Cancer
A phase II, multi-center, open-label, randomized trial. BSI-201 is a PARP inhibitor, a novel therapeutic strategy where DNA repair is compromised. This drug targets & inhibits PARP, which plays a central role in tumor survival by regulating DNA repair, cell proliferation and by controlling gene transcription. (09-008)

GASTROINTESTINAL CANCER

FOLFIRI + Pantiumumab or FOLFIRI + Bevacizumab in Metastatic Colorectal Cancer
This is a study for patients with metastatic adenocarcinoma of the colon or rectum who have failed their first line treatment containing Flouropyrimidine and Oxaliplatin based chemotherapy with Bevacizumab. They must have at least one uni-dimensionally measurable lesion and adequate hematologic, renal, hepatic and metabolic function. They will be treated with either FOLFIRI (leuvcovorin, fluorouracil and irinotecan) plus Panitumumab or FOLFIRI plus Bevacizumab. (07-141)

Docetaxel + Oxaliplatin +/- Cetuximab
This phase II study will look at the efficacy and safety of combining Cetuximab, an EGFR1 inhibitor, with standard chemotherapy for metastatic gastric cancer. (06-063)

Study with FOLFIRI + Study Drug for KRAS-Mutant Metastatic Colorectal Cancer
This is a double-blind, placebo-controlled study evaluating the safety and efficacy of FOLFIRI (leuvcovorin, fluorouracil and irinotecan) in combination with AMG 479 or AMG 655 vs FOLFIRI for second-line treatment of KRAS-mutant metastatic colorectal carcinoma. (08-137)

GENITOURINARY CANCER

Pazopanib vs Sunitinib for Patients with Metastatic Renal Cell Carcinoma
This study is for those with a diagnosis of renal cell carcinoma with clear-cell component histology who have received no prior systemic therapy for advanced or metastatic RCC. There are two arms: Pazopanib 800mg PO QD or Sunitinib 50 mg PO QD. (08-060)

LYMPHOMA/MEYLOMA

Velcade Plus Either Dexamethasone, Dexamethasone + Thalidomie or Melphalan + Prednisone for First-Line Treatment of Multiple Myeloma
This is a study for myeloma patients who are not candidates for high-dose chemotherapy. Patients are randomized to receive either Velcade + Thalidomide + Dexamethasone OR Velcade + Dexamethasone OR Velcade + Melphalan + Prednisone for 8 cycles of 21 days each. This is followed by maintenance Velcade. (06-108)

Faster Infusion of Rituximab for Patients with Non-Hodgkin’s Lymphoma
Phase III, multicenter study of Rituximab at a faster infusion time in patients with previously untreated diffuse large B cell of follicular non-hodgkin’s lymphoma. (U4391g)

LUNG

Study with Tarceva for Patients with Stage IB-IIIA Non-Small Cell Lung Cancer
This is a multi-center, randomized, double-blind, placebo-controlled, phase III study of Tarceva (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung cancer who have EGFR-positive tumors. (06-026)

Talactoferrin vs Placebo Study for Patients with Stage IIIB or IV Non-Small Cell Lung Cancer Who Have Failed at Least Two Prior Systemic Regimens
This metastatic, 3rd line treatment uses Talactoferrin 1.5g pill taken twice a day or placebo pill at a 2:1 ratio. It includes 12 weeks on study drug with a two week rest for up to five 14-week cycles (70 weeks). (07-057)

Sunitinib for NSCLC in Patients with an age greater than 70
A phase II trial. Sunitinib (SU11248) is an oral, multi-targeted tyrosine kinase inhibitor with anti-angiogenic, and anti-tumor activities due to selective inhibition of several receptor tyrosine kinases. Activation of gene pathways by hypoxia, such as vascular endothelial growth factor (VEGF) and epidermal growth factor (EGF), are common in solid tumors. These genes are implicated in tumor angiogenesis and proliferation. (06-135)

Pemetrexed / Carboplatin / Bevacizumab vs Taxol / Carboplatin / Bevacizumab
Study compares efficacy and safety of substituting Pemetrexed, a pryimidine-based folate analog, for Taxol (standard of care). (08-044)

CP-751,871 in Combination with Paclitaxel and Carboplatin vs Paclitaxel and Carboplatin in NSCLC
A randomized, open-label, phase II study that will determine the safety and efficacy of standard chemotherapy in combination with CP-751,871, an IGF-1R (Insulin growth factor receptor) inhibitor. The Insulin-like Growth Factor (IGF) pathway is a fundamental mechanism of cell growth and survival. Evidence from preclinical and clinical studies suggests that signaling through IGF-1R-mediated pathways regulates multiple processes of cancer initiation, progression, and in some instances, resistance to therapy. Tumor cells appear to rely on the IGF-1R signaling pathway as a pro-survival and anti-apoptotic mechanism that: facilitates malignant transformation, causes growth and progression of established tumors, enhances tumor invasion and metastasis and contributes to resistance to therapy by providing an escape pathway for tumor cells. (08-005)

Darbepoetin Alfa for Anemia in Patients with Advanced Non-Small Cell Lung Cancer receiving Multi-cycle Chemotherapy
A randomized, double-blind, placebo-controlled study to evaluate the long-term safety and efficacy of Darbepoetin Alfa administered at 500 mg once every three weeks in anemic subjects. Darbepoetin is an erythropoiesis stimulating agent that is commonly used to treat anemia in patients receiving chemotherapy. This study will focus on the long-term efficacy and safety of the drug used in the Q3 weeks schedule. (08-035)

Trial Designed to Evaluate the Preliminary Activity and Safety of Treatment with MetMAb + Erlotinib vs Placebo + Erlotinib in Non-Small Cell Lung Cancer Patients
A study for people with recurrent or progressive lung cancer who have had at least one chemotherapy containing regimen for stage IIIB/IV disease. Patients who receive neo-adjuvant and/or adjuvant therapy for stage I-IIIA disease prior to their first-line regimen for stage IIIB/IV disease are eligible. At least one of the chemotherapy regimens must have been platinum-based. Patients will receive either MetMAb plus Erlotinib or Erlotinib plus placebo. (MetMAb)

MELANOMA

Treatment with OncoVEX/GM-CSF vs Subcutaneously Administered GM-CSF in Previously Treated Melanoma Patients with Resectable Stage IIIB, IIIC and Stage IV Disease
This is a multi-national, open-label, randomized phase III study to assess OncoVEX GM-CSF monotherapy or control in patients with unresectable, stage IIIB/C or IV Melanoma. Patients entering this study must have received at least on prior therapy for active disease (radiation, isolated lim perfusion, chemotherapy or biotherapy). (BioVex)

MISC

Registry Trial for “Iron Overload” Patients
This is a registry trial for Myelodysplastic Syndrome. It collects data at baseline and every six months for up to five years, investigating iron chelation and the impact on endocrine, cardiac, hepatic, hematologic, renal, ocular and auditory function. There are not any drugs, scans, lab work, etc required by the study. (07-168)

Study for Patients with Hepatocellular Carcinoma That Will Be Starting Nexavar
This is a study for patients with unresectable hepatocellular carcinoma who are candidates for systemic therapy and for whom a decision to treat with Nexavar has been made but not yet started. The treatment with Nexavar will comply with the recommendations written in the local product information, but the decision on the duration and dose of treatment is solely at the discretion of the prescribing physician. (08-142)