Overview
A Study of Bevacizumab (Avastin) in Combination With Dacarbazine in Participants With Unresectable/Metastatic Melanoma
Status:
Completed
Completed
Trial end date:
2012-05-31
2012-05-31
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hoffmann-La RocheTreatments:
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