Phase 2
N=146
A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).
Renal Cell Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00796757 ↗Enrolled (actual)
146
Serious AEs
17.8%
Results posted
May 2015
Primary outcome: Primary: Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months — 58.2; 28.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab [Avastin] (Drug); interferon alfa-2a (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months |
58.2; 28.9 | — |
| PRIMARY PFS - Percentage of Participants With an Event |
69.2 | — |
| PRIMARY PFS - Time to Event |
15.3 | — |
| SECONDARY Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR) |
28.8 | — |
| SECONDARY Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months |
84.1; 59.6 | — |
| SECONDARY OS - Percentage of Participants With an Event |
41.8 | — |
| SECONDARY OS - Time to Event |
30.7 | — |
| SECONDARY Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit |
69.0; 31.0; 64.2; 35.8; 58.0; 42.0 | — |
| SECONDARY EQ-5D - Visual Analog Scale (VAS) |
71.2; 71.8; -1.8; 72.4; -2.3; 71.3 | — |
Summary
This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- metastatic RCC with majority (>50%) of conventional clear-cell type;
- prior total nephrectomy for primary RCC;
- at least one measurable or non-measurable lesions;
- ECOG performance score of 0 or 2.
Exclusion Criteria
- prior systemic treatment for metastatic RCC;
- current or previously treated but non-stable CNS metastases or spinal cord compression;
- major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment;
- significant cardiovascular disease within 6 months prior to enrollment.
Data sourced from ClinicalTrials.gov (NCT00796757). 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.