Clinical Trial Protocol Registry
A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma
- Protocol number:
- Roche S.p.A.
- Company division:
- 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 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. Target sample size is 20.
- Study phase:
- Study type:
- Interventional; Treatment; Non-randomized; Uncontrolled; Single group; Safety/efficacy study
- Malignant Melanoma
- Intervention type:
- Intervention name:
- bevacizumab [Avastin]
- Primary outcome:
- Overall response rate (ORR) Time frame: From study start through study completion or early study discontinuation
- Key secondary outcomes:
- Time to progression (TTP) Time frame: From start of treatment to the onset of disease progression, or death, or the last date the patient was known to be progression-free or alive
- Duration of response (DR) Time frame: From the day of response evidence to the day of disease progression
- Overall survival (OS) Time frame: From start of treatment up to death or the last date the patient was known to be alive
- Time to treatment failure (TTF) Time frame: From start of treatment to evidence of treatment failure
- Frequency of adverse events (AEs) Time frame: From study start through study completion or early study discontinuation
- 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.
- Males or Females
- Age limits:
- Min: 18 years Max: N/A N/A
- Accepts healthy volunteers:
- Trial registration date:
- Date last updated:
For more information on a specific Roche trials in your country location, please contact your local Roche affiliate nearest you.
- Go on the URL link- http://www.roche.com and click on the Roche Worldwide tab on the top of the page to locate the country nearest you for contact information.
Treatment decisions and/or suitability for a specific trial are decisions only your healthcare provider can make. If you are patient interested in any of the global studies, please have your healthcare provider contact us and they will be provided with the relevant clinical trial information.
For US or global trials with US sites only, please contact the Trial Information Support Line (TISL)
- 1-888-662-6728 Monday to Friday (6am to 3pm PST)