Status:
COMPLETED
Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 treat...
Eligibility Criteria
Inclusion
- 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
- Ocular melanomas
- Brain Metastases
- Prior cytokine or chemotherapy for stage IV disease
- Pregnant or nursing women
Key Trial Info
Start Date :
October 20 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2007
Estimated Enrollment :
859 Patients enrolled
Trial Details
Trial ID
NCT00091572
Start Date
October 20 2004
End Date
December 31 2007
Last Update
June 6 2017
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