Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melanoma
Intervention: Temozolomide (Drug); Dacarbazine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall Survival
Secondary outcome: Progression Free SurvivalObjective Response Rate in Subjects With Measurable Lesions Duration of Objective Response
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: October 2004
Last updated: April 28, 2015
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