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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Malignant Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

15 mg/kg intravenously on day 1 of every 3 week cycle

fotemustine

Intervention Type DRUG

100 mg/m² intravenously on Days 1, 8, and 15, followed by 4 weeks of rest, then every 21 days up to 4 to 6 cycles

Interventions

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bevacizumab [Avastin]

15 mg/kg intravenously on day 1 of every 3 week cycle

Intervention Type DRUG

fotemustine

100 mg/m² intravenously on Days 1, 8, and 15, followed by 4 weeks of rest, then every 21 days up to 4 to 6 cycles

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No