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Taxotere/Temodar/Cisplatin Study in Melanoma Patients

NCT00527761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2012-07-30

No results posted yet for this study

Summary

Primary Objective:

1\. To determine the maximum tolerated dose of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma.

Secondary Objectives:

1. To determine the toxicity of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma
2. To determine the response rate of induction chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma.

Conditions

Interventions

DRUG

Cisplatin

20 mg in 500 ml of normal saline by vein over 60 minutes daily for 4 days starting on day 1 of chemotherapy.

DRUG

Docetaxel

Starting dose 20 mg by vein over 1 hour, once a week, for three weeks (on Days 1, 8, and 15).

DRUG

Temodar

150 mg by mouth (PO) on Days 1 - 5.

Sponsors & Collaborators

  • Aventis Pharmaceuticals

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Kevin B. Kim, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00527761 on ClinicalTrials.gov