E4805 - A Randomized Phase II Study to Determine the Effect of-2 Different Doses of AVE0005 (VEGF Trap) in Patients with Metastatic Renal Cell Carcinoma
Description
E4805 - A Randomized Phase II Study to Determine the Effect of-2 Different Doses of AVE0005 (VEGF Trap) in Patients with Metastatic Renal Cell Carcinoma
Primary:
•To determine the effect of two different doses of AVE0005 (VEGF Trap) treatment on the progression-free proportion at 8 weeks in patients with metastatic renal cell carcinoma who had previous treatment with a tyrosine kinase inhibitor (TKI).
Secondary:
•To determine the effect of AVE0005 (VEGF Trap) treatment on objective response rate in patients with metastatic renal cell carcinoma who have had previous TKI treatment.
•To describe progression-free survival among patients who undergo dose escalation following progression on low-dose AVE0005 (VEGF Trap).
•To evaluate the safety and tolerability of AVE0005 (VEGF Trap) in patients with metastatic renal cell carcinoma who have had previous treatment with a TKI.
•To determine the circulating levels of VEGF AVE0005 (VEGF-Trap) complex and correlate it with clinical activity.
• To evaluate the modulation of specific angiogenesis-related protein expression by AVE0005 (VEGF-Trap).
Study/Treatment
Renal Cell Carcinoma Cancer Trial
Inclusion/Notes
Eligibility Criteria:
Patient must have histologically confirmed metastatic or unresectable renal cell carcinoma. Disease must be conventional clear cell carcinoma or have a component of clear cell carcinoma.
Patients with true papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors and transitional cell carcinoma are NOT eligible.
Patient must have measurable lesions according to the RECIST criteria.
Baseline measurements must be performed =4 weeks prior to randomization.
Patient must have evidence of progressive disease following treatment with a tyrosine kinase inhibitor (TKI).
Patient must have received at least one prior treatment with a receptor tyrosine kinase inhibitor (i.e. sunitinib and/or sorafenib) for at least 12 weeks. Prior treatment with either temsirolimus or everolimus is allowed. Prior immunotherapy is limited to cytokine therapy with interleukin 2 and interferon alpha only. No other prior immunotherapy is allowed. No prior treatment with bevacizumab is allowed.
No prior chemotherapy, cellular therapy, vaccine therapy or hormonal therapy is allowed.
Previous radiotherapy (RT) is permissible provided the measurable disease is outside the RT port. RT must be completed = 3 weeks prior to randomization.
Patient must be 18 years of age or older.
Patient must have an ECOG performance status 0-2.
Patient must have recovered from any toxic effects of prior radiotherapy or surgical procedures within 4 weeks prior to randomization.
Patient must have adequate organ function as defined by the following criteria < 4 weeks prior to randomization: SGOT (AST) and SGPT (ALT) =3 x ULN, total serum bilirubin =1.5 x ULN, absolute neutrophil count (ANC) =1 x 109/L, platelet count =100 x 109/L, hemoglobin =8.0 g/dL, serum calcium =12.0 mg/dL, calculated creatinine clearance (CrCl) =60 mL/min, and either proteinuria =500 mg/24 hours or urine protein:creatinine ratio (UPCR) =1,international normalized ratio (INR) within normal limits (or =1.5 x ULN if on prophylactic anticoagulation) and activated partial thromboplastin time (aPTT) within normal limits.
Patient must not have known history of metastatic CNS disease.
Female patients MUST NOT be pregnant or breastfeeding. For women of childbearing potential, a negative serum pregnancy test is required within 1 week prior to randomization.
Patients who have had basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast, or lobular carcinoma in situ of the breast within the past five years are eligible only if treated with curative intent.
Patients with other malignancies are eligible only if they have been continuously disease-free for > 5 years prior to the time of randomization.
Start Date
10/19/2010
Principal Name
O. George Negrea, M.D.
Contact Name
Nancy N. and J.C. L
Fax
(912) 081-5705
Phone
(912) 819-5704
Nancy N. and J.C. Lewis Cancer & Research Pavilion225 Candler Drive, Savannah, Georgia 31405
