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

NCT00091572 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 859

Last updated 2017-06-06

Study results available
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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.

Conditions

Interventions

DRUG

Temozolomide

oral capsule; 150 mg/m2/day PO (by mouth), on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously); one cycle of temozolomide is defined as a 6-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.

DRUG

Dacarbazine

intravenous solution; dacarbazine 1000 mg/m2 IV (in the vein), on Day 1 +/- 3 days every 3 weeks; one cycle of dacarbazine is defined as a 3-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • Merck Sharp & Dohme LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-20
Primary Completion
2007-12-31
Completion
2007-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00091572 on ClinicalTrials.gov