Status:
COMPLETED
Combination of Temsirolimus and Bevacizumab in Patient With Metastatic Renal Cell Carcinoma
Lead Sponsor:
Centre Leon Berard
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Eligib...
Detailed Description
This is a phase II, open label, randomized, parallel group, multicenter study evaluating first-line treatment of patients with metastatic renal cancer using a combination of Torisel® administered intr...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2012
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00619268
Start Date
February 1 2008
End Date
February 1 2012
Last Update
February 15 2013
Active Locations (29)
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1
Centre Paul Papin
Angers, France
2
Centre Hospitalier Universitaire de Besançon
Besançon, France
3
Centre Hospitalier Universitaire de Bordeaux - Hôpital St André
Bordeaux, France
4
Institut Bergonié
Bordeaux, France