Trial information
A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma.
Status: No longer recruiting
Protocol number: ML19309
Sponsor: Roche S.p.A.
Company division: Pharmaceutical
Official Scientific Title: An open-label study to assess the anti-tumor activity of Avastin in combination with fotemustine as first-line therapy in patients with metastatic melanoma
Brief summary: This study will investigate the efficacy and safety of Avastin + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg 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. Target sample size is 36.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Malignant Melanoma
Intervention type: Drug
Intervention name: bevacizumab[Avastin]
Primary outcome: 1. Overall response rate
Key secondary outcomes: 1. Efficacy: complete remission, partial remission, stable disease, progressive disease, overall survival. Safety: Adverse events, laboratory parameters.
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: January, 2007
Trial registration date: 10/17/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Italy
