Combination of Temsirolimus and Bevacizumab in Patient With Metastatic Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The TORAVA trial is designed to evaluate the progression-free rate at 48 weeks of a combination of Torisel® and Avastin® given at first-line treatment in patients with metastatic renal cancer.

Eligible patients will be randomly assigned, in a 2:1:1 ratio, to either Avastin® + Torisel®, or Sutent® or IFN+Avastin®.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard
• Treatments: Bevacizumab; Everolimus; Interferon alpha-2; Interferon-alpha; Interferons; Sirolimus; Sunitinib

Criteria

Inclusion Criteria:

• Male or female patients>= 18 years of age;

• Patients with histological or cytological evidence of metastatic renal cell carcinoma mostly of all type,except for papillary;

• No prior systemic treatment (chemotherapy, immunotherapy, anti-angiogenic drugs, or treatment under evaluation) for metastatic renal cancer;

• No brain metastases revealed by MRI or CT-scan within 28 days prior to randomization. Patients with a history of brain metastases treated by surgery +/- radiation therapy can be included if they have normal brain MRI;

• E.C.O.G performance status =<2;

• At least one measurable lesion using the RECIST criteria;

• Blood tests and renal and liver functions in the normal range with, in the 7 days prior to study entry, blood or serum values as follows:

Hemoglobin > 8g/dl; Neutrophil count > 1500*10exp9/L; Platelets > 100*10exp9/L; Serum creatinine < 200µmol/L; Total Bilirubin < 1.5 times upper limit of normal; ALT and AST < 2.5 times upper limit of normal or < 5 ULN for patients with liver metastases, PT or INR < 1.5 times upper limit of normal in the absence of anticoagulant therapy;

• Absence of proteinuria confirmed by urinary dipstick test

• Fertile women must use effective means of contraception

• Mandatory affiliation with a healthy security insurance

• Signed written informed consent.

Exclusion Criteria:

• Patient with pure papillary renal cell carcinoma

• Prior systemic treatment for metastatic renal cancer

• History of other malignancies, other than curatively treated in-situ carcinoma of the cervix or basal cell carcinoma of the skin, or any other curatively treated cancer with no sign of recurrence within 5 years prior to randomization

• Evidence of brain metastasis by computerized tomographic scan or MRI in the 28 days prior to randomization. Patients with history of brain metastases treated by exclusive brain therapy are not allowed to participate, even if brain MRI is normal

• Significant cardiovascular disease or uncontrolled hypertension while receiving appropriate medication (>= 160 mm Hg systolic and/or >= 90 mm Hg diastolic)

• Hepatic affection like chronic advanced hepatitis, liver cirrhosis or chronic hepatitis recently treated or in process of treatment by immunosuppressive agents, hepatitis auto-immune or history of auto-immune disease

• Major surgical procedure, open biopsy, or serious non healing wound within 28 days prior to randomization

• Uncontrolled hypercalcemia while receiving appropriate treatment

• Uncontrolled hypercholesterolemia or hypertriglyceridemia

• Patient under anti-vitamin K therapy

• Patient under strong CYP3A4 inhibitors

• Patient with severe neuropsychiatric disorder (or comitial crises)

• Patient included in another clinical trial, except for supportive care trials

• Pregnant or lactating women (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential)