Phase 2 N=25 Treatment

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

Renal Cell Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00520403 ↗

Enrolled (actual)

Serious AEs

32.0%

Results posted

Oct 2014

Primary outcome: Primary: Percentage of Participants With Disease Progression or Death — 66.9 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bevacizumab [Avastin] (Drug); Interferon alfa-2a (Drug); Vinblastine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Disease Progression or Death	66.9	—
PRIMARY PFS - Time to Event	274	—
SECONDARY Percentage of Participants With Objective Response (OR)	21.4; 31.3; 37.5; 31.3; 31.3	—
SECONDARY Overall Survival (OS)	NA	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00520403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.