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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted18 and overPharmaceutical / IndustryP03267

Trial Description


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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Merck and Company, Incorporated

  • European Organization for Research and Treatment of Cancer

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00091572
ClinicalTrials.gov processed this data on May 14, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.