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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Cell Cancer

Intervention: bevacizumab [Avastin] (Drug); Interferon alfa-2a (Drug); Vinblastine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

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.

Clinical Details

Official title: 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.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Percentage of Participants With Disease Progression or Death

PFS - Time to Event

Secondary outcome:

Percentage of Participants With Objective Response (OR)

Overall Survival (OS)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adult patients, >=18 years of age;

- metastatic renal cell cancer of predominantly clear cell type;

- >=1 measurable lesion.

Exclusion Criteria:

- prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for

metastatic renal cell cancer;

- ongoing or recent need for full therapeutic dose of anticoagulants or chronic daily

treatment with aspirin (>325mg/day);

- clinically significant cardiovascular disease.

Locations and Contacts

Berlin 10117, Germany

Berlin 10967, Germany

Bremen 28277, Germany

Dessau 06846, Germany

Erlangen 91052, Germany

Frankfurt 60596, Germany

Halle 06097, Germany

Hannover 30449, Germany

Jena 07743, Germany

Kassel 34125, Germany

Kiel 24105, Germany

Leipzig 04103, Germany

Magdeburg 39120, Germany

Rehling 86058, Germany

Stuttgart 70174, Germany

Weiden 92637, Germany

Additional Information

Starting date: September 2007
Last updated: October 9, 2014

Page last updated: August 23, 2015

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