Overview

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

Status:
Completed
Trial end date:
2012-05-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Bevacizumab
Dacarbazine
Criteria
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