Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)

• Status: Completed
• Trial end date: 2007-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to ascertain if the extended schedule of Temozolomide, which allows increased doses and potential depletion of the enzyme underlaying resistance, is a more effective treatment of metastatic melanoma than single agent dacarbazine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• Histologically confirmed, stage IV, surgically incurable melanoma

• Age 18 years or older

• World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Meets protocol requirements for specified laboratory values

• Must be able to take oral medication

• Must be disease free from cancer for period of 5 years (except for surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin).

• Women of childbearing potential and men must be practicing a medically approved contraception.

• Must provide written informed-consent to participate in the study.

• Must have full recovery from major surgery or adjuvant treatment

• No clinically uncontrolled infectious disease including HIV or AIDS-related illness

Exclusion Criteria:

• Ocular melanomas

• Brain Metastases

• Prior cytokine or chemotherapy for stage IV disease

• Pregnant or nursing women