Phase 2
Completed N=25
A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.
Source: ClinicalTrials.gov NCT00520403 ↗Enrolled (actual)
25
Serious AEs
32.0%
Results posted
Oct 2014
Primary outcomePrimary: Percentage of Participants With Disease Progression or Death — 66.9 percentage of participants
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.
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 | — |
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.
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. Informational only — not medical advice.