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 DeathPFS - 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
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