Dose-finding and Phase II study of the Combination of Bevacizumab rhuMAb VEGF plus low- dose Immunotherapy and Chemotherapy in patients with metastatic Renal Cell Cancer. - Bevacizumab Chemoimmunotherapy in RCC

• Conditions: Patients with metastatic Renal Cell Cancer; MedDRA version: 6.1Level: PTClassification code 10050018

• Registration Number: EUCTR2005-005670-71-IT
• Lead Sponsor: GRUPPO ONCOLOGICO ITALIANO DI RICERCA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Histologically or cytologically proven diagnosis of renal cancer of the clear-cell type. Other histological variants will be admitted only if the clear cell component is at least 50 of the total neoplastic cells 2. Previous nephrectomy. 3. Metastatic cancer pretreated or not previously treated with chemotherapy and/or immunotherapy. 4. Age 18. 5. ECOG Performance Status 0-1. 6. Life expectancy of at least 12 weeks. 7. Measurable and/or evaluable lesions according to RECIST criteria. 8. Good bone, hepatic and renal functionality.Urine dipstick of proteinuria 2 . Patients discovered to have 2 proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate 1 g of protein/24 hr. 9. Written informed consent. 10. Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating center.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Brain metastases. 2. Previous allogenic bone marrow- transplantation 3. History of inflammatory bowel disease and/or acute/subacute bowel occlusion. 4. Serious non-healing wound or ulcer. 5. Evidence of bleeding diathesis or coagulopathy. 6. Uncontrolled hypertension. 7. Clinically significant i.e. active cardiovascular disease for example cerebrovascular accidents 6 months , myocardial infarction 6 months , unstable angina, New York Heart Association NYHA grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. 8. Current or recent within 10 days prior to study treatment start ongoing treatment with anticoagulants for therapeutic purposes. 9. Chronic, daily treatment with high-dose aspirin 325 mg/day or other medications known to predispose to gastrointestinal ulceration. 10. Treatment with any investigational drug within 30 days prior to enrollment. 11. Patients with known allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications. 12. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. 13. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study. 14. Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of nonchildbearing potential. Sexually active males and females of childbearing potential unwilling to practice contraception during the study. 15. Rendu-Osler-Weber syndrome.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the preliminary antitumor activity in terms of overall response rate complete and partial responses of the combination.;Primary end point(s): MAIN PARAMETERS OF ACTIVITY Overall objective tumor response rate complete response, partial response, stable disease and progressive disease according to the RECIST criteria. according to the RECIST criteria.;Secondary Objective: To determine the maximum tolerated dose MTD , the dose-limiting toxicity DLT and the recommended dose of fixed doses of Bevacizumab, Interleukin-2 and Interferon- alpha, in combination with excalating doses of Gemcitabine and 5-Fluorouracil. To evaluate toxicity and the safety profile of the combination. To evaluate duration of response DR , time to progression TTP , time to treatment failure TTF , and overall survival OS .