Roche trials database

Trial information

A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma

Status:

Completed

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 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:

II

Study type:

Interventional; Treatment; Non-randomized; Uncontrolled; Single group; Safety/efficacy study

Conditions:

• Malignant Melanoma

Intervention type:

Drug

Intervention name:

bevacizumab [Avastin]

Primary outcome:

1. Overall response rate (ORR) Time frame: From study start through study completion or early study discontinuation

Key secondary outcomes:

1. 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
2. Duration of response (DR) Time frame: From the day of response evidence to the day of disease progression
3. Overall survival (OS) Time frame: From start of treatment up to death or the last date the patient was known to be alive
4. Time to treatment failure (TTF) Time frame: From start of treatment to evidence of treatment failure
5. 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.

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A N/A

Accepts healthy volunteers:

No

Trial registration date:

09.08.2006

Date last updated:

16.12.2010

This trial was conducted at the following locations:

Italy

• FIRENZE
• GENOVA
• MILANO
• TORINO

Link to trial result