A Study of Bevacizumab (Avastin) in Combination With Dacarbazine in Participants With Unresectable/Metastatic Melanoma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2012-05-31

Brief Summary

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This study will assess the preliminary anti-tumor activity and safety profile of a combination of bevacizumab and dacarbazine in participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease.

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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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Dacarbazine + Bevacizumab

Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease will receive dacarbazine and bevacizumab until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Bevacizumab will be given as 10 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Days 1 and 14 of each 28-day cycle.

Dacarbazine

Intervention Type DRUG

Dacarbazine will be given as 800 milligrams per square meter (mg/m\^2) via IV infusion on Day 1 of each 28-day cycle.

Interventions

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Bevacizumab

Bevacizumab will be given as 10 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Days 1 and 14 of each 28-day cycle.

Intervention Type DRUG

Dacarbazine

Dacarbazine will be given as 800 milligrams per square meter (mg/m\^2) via IV infusion on Day 1 of each 28-day cycle.

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed cutaneous malignant melanoma
* Clinical evidence of metastatic disease and/or unresectable regional lymphatic disease and/or extensive in transit recurrent disease
* Measurable and/or evaluable lesions according to RECIST

Exclusion Criteria

* Prior interferon alfa and/or cytokine therapy for metastatic disease
* Prior chemotherapy for metastatic disease
* Brain metastases
* Chronic daily treatment with high-dose aspirin (more than 325 milligrams per day)
* Other co-existing malignancies or malignancies diagnosed within the past 5 years with the exception of basal cell cancer or cervical cancer in situ

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No