Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Carcinoma, Renal Cell

Disease Progression

Carcinoma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Bevacizumab

Vinblastine

Interferons

Interferon-alpha

Interferon alpha-2

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antiviral Agents

Immunologic Factors

Tubulin Modulators

Antimitotic Agents

bevacizumab [Avastin]

3 MioIU sc escalating to 18 MioIU sc, 3 times weekly

Interferon alfa-2a

Clinical Trials

This single arm study will assess the efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3 weeks. The anticipated time on study treatment is until tumor progression, and the target sample size is 100-500 individuals.

A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.

An Open-label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Standard Therapy on Progression-free Survival in Patients With Metastatic Renal Cell Cancer.

Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination.

PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method

Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST.

OS was defined as the duration from treatment start to death from any cause. Overall survival was censored at the last contact for surviving participants and missing data points.

Hoffmann-La Roche

AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).

Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).

Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.

If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression.

Bevacizumab + IFN/Vinblastine

Age, Continuous

Sex: Female, Male

Safety Population: included all participants, even those who withdrew from the study prematurely and who received at least 1 dose of bevacizumab and had a safety follow-up visit.

Medical Communications

Intent-to-treat (ITT) population: all participants, even those who withdrew from the study prematurely, who received at least 1 dose of study medication and for whom the primary efficacy variable was measured at least once during the time when the participant received study medication.

Percentage of Participants With Disease Progression or Death

Week 9 (n=14)

Week 18 (n=16)

Week 27 (n=16)

Week 39 (n=16)

Week 51 (n=16)

ITT Population; missing data were imputed using the last observation carried forward (LOCF) technique. Number (n) equals (=) number of participants assessed at each specific visit.

Percentage of Participants With Objective Response (OR)

Two of 25 participants died during the course of the study, thus, median overall survival could not be analyzed.

Overall Survival (OS)

PFS - Time to Event

Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg intravenously (IV) and bevacizumab 15 milligrams per kilogram (mg/kg) IV on Day 1 followed by 2 weeks off and IFN subcutaneous (SC) injection three times per week (starting on Day 1) at doses of 3 million International Units (mIU) (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).

Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3; the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.

If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression.

Bevacizumab + Interferon Alfa-2a (IFN)/Vinblastine

Bevacizumab Monotherapy

Spots Global Cancer Trial Database for A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial