Phase 2
Completed N=20
A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma
Source: ClinicalTrials.gov NCT01069627 ↗Enrolled (actual)
20
Serious AEs
20.0%
Results posted
Jun 2014
Primary outcomePrimary: Percentage of Participants With Complete Response (CR) or Partial Response (PR) — 15 percentage of participants
Summary
This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously[IV]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) |
15 | — |
| PRIMARY Percentage of Participants With Clinical Benefit of CR, PR, or Stable Disease (SD) |
65 | — |
| SECONDARY Time to Progression (TTP) - Percentage of Participants With an Event |
73.68 | — |
| SECONDARY TTP - Time to Event |
249.00 | — |
| SECONDARY Duration of CR - Percentage of Participants With an Event |
— | — |
| SECONDARY Duration of CR - Time to Event |
NA | — |
| SECONDARY Duration of Overall Response of CR or PR - Percentage of Participants With an Event |
66.67 | — |
| SECONDARY Duration of Overall Response of CR or PR - Time to Event |
324.00 | — |
| SECONDARY Duration of Stable Disease - Percentage of Participants With an Event |
58.33 | — |
| SECONDARY Duration of Stable Disease - Time to Event |
619.00 | — |
| SECONDARY Overall Survival (OS) - Percentage of Participants With an Event |
60 | — |
| SECONDARY OS - Time to Event |
615.00 | — |
| SECONDARY Time to Treatment Failure (TTF) - Percentage of Participants With an Event |
100 | — |
| SECONDARY TTF - Time to Event |
126.00 | — |
| SECONDARY Time to CR - Percentage of Participants With an Event |
5.26 | — |
| SECONDARY Time to CR - Time To Event |
76.00 | — |
| SECONDARY Time to Overall Response of CR or PR - Percentage of Participants With an Event |
15.79 | — |
| SECONDARY Time to Overall Response of CR or PR - Time to Event |
116.50 | — |
Eligibility Criteria
Inclusion Criteria
- cutaneous malignant melanoma;
- advanced, inoperable stage IV melanoma;
- measurable and/or evaluable sites of metastases.
Exclusion Criteria
- prior chemotherapy and/or IFN/IL2 based immunotherapy for metastatic disease;
- prior malignancies within past 5 years, with the exception of cured non-melanoma skin cancer, or in situ cancer of cervix;
- clinically significant cardiovascular disease;
- ongoing treatment with aspirin (>325mg/day) or other medications known to predispose to gastrointestinal ulceration.
Data sourced from ClinicalTrials.gov (NCT01069627). 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.