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Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma

NCT00087776 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 393

Last updated 2025-07-23

No results posted yet for this study

Summary

The primary objective of this trial is to compare the survival of patients with metastatic malignant melanoma treated with Taxoprexin Injection to those treated with Dacarbazine. In addition, the response rate to each drug, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.

Conditions

  • Malignant Melanoma

Interventions

DRUG

Taxoprexin

Administered by intravenous infusion over 2 hour infusion on Day 1 followed by a 20-day observation period for a total of 21 days (three weeks) per course

DRUG

Dacarbazine

Administered by intravenous infusion over 30 minutes on Day 1 followed by a 20-day observation period for a total of 21 days (three weeks) per course

Sponsors & Collaborators

  • American Regent, Inc.

    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
2002-12-06
Primary Completion
2007-10-27
Completion
2007-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT00087776 on ClinicalTrials.gov