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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 Survival

Objective 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

Page last updated: August 20, 2015

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