Taxotere/Temodar/Cisplatin Study in Melanoma Patients

Metastatic Melanoma Clinical Trial

Official title: Phase I Study of TTC (Taxotere/Temodar/Cisplatin) in Metastatic Melanoma Patients

Status Completed

Clinical Trial 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.

Clinical Trial Description

Temozolomide, docetaxel, and cisplatin are "chemotherapy" drugs, known to kill tumor cells by interfering with the important structures in these cells to grow and divide. Each of these drugs has been used separately for melanoma treatment. These 3 drugs have not been used in combination.

Before you can start treatment on the study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam, including routine blood tests (less than 3 tablespoons). You will have an electrocardiogram (EKG - test to measure the electrical activity of the heart), a chest x-ray, and CT scans of the chest and abdomen. You will have a MRI or CT scan of brain will as well. Depending on the location of melanoma, CT scans of the head and neck or pelvis and/or a bone scan may be taken. Photographs of the tumor may be taken if the tumors are located on the surface of the skin. Women who are able to have children must have a negative blood pregnancy test.

If you are found to be eligible, you will receive temozolomide, cisplatin, and docetaxel. The doses of temozolomide and cisplatin will be fixed for all groups. The dose of docetaxel will be changed between patient groups until the highest safe dose is found Between 3 and 6 patients will be enrolled in each group. Docetaxel will be given by vein over 1 hour, once a week, for three weeks (on Days 1, 8, and 15). This will be followed by one week of rest. These 3 weeks of treatment and 1 week or rest make up 1 cycle. Cisplatin will be given by vein once a day for four days in a row (Days 1, 2, 3 and 4) over 2 hours each cycle. Temozolomide will be taken by mouth for five days in a row (Days 1, 2, 3, 4 and 5) of each cycle. The number of temozolomide pills that you take will be based on your height and weight. Temozolomide must be taken on an empty stomach (at least 2 hours before or after meals).

For your comfort in receiving cisplatin and docetaxel by vein, your doctor may recommend a catheter. A catheter is a plastic tube that is inserted into a vein in one of your arms or into the vein that runs underneath the collar bone, and then threaded into the central vein in the upper part of the chest.

The first dose of docetaxel and all of the cisplatin doses must be given at M.D. Anderson on an outpatient basis. All of the temozolomide doses can be taken at home and the Day 8 and Day 15 doses of docetaxel can be taken at a local clinic.

You may receive granulocyte colony-stimulating factor (G-CSF) to help the body produce new blood cells. G-CSF would be given as an injection under the skin on Days 9-13 of each cycle (except the first cycle).

During the study, you will have a complete physical exam every 4 weeks. Blood samples (1 tablespoon or less) will be taken weekly to monitor the blood counts and liver functions. A chest x-ray and CT scans of the chest and abdomen with or without head and neck and pelvis will be done every 2 cycles (8 weeks). A MRI or CT scan of the brain as well as photographs may also be taken every 2 cycles during the study. For patients who have significant tumor shrinkage with the treatment, these imaging studies may be repeated in 4 weeks.

All participants can receive at least 6 cycles of treatment. If your tumor continues to shrink after the end of 6 cycles, you may be eligible to receive further treatment at the discretion of the study chair. You may be taken off study early, if your disease gets worse or intolerable side effects occur.

You will have one last "follow-up" visit once you are taken off study. At this visit you will have a complete physical exam and blood samples (1 tablespoon) for routine tests will be taken. You will have a chest x-ray and CT scans of the chest and abdomen, with or without head and neck and pelvis, and with or without a MRI of brain at this visit as well.

This is an investigational study. The FDA has approved all of the drugs in this study, and they are commercially available. However, their use together in this study is experimental. Up to 30 patients will take part in this study. All will be enrolled at M.D. Anderson. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

• NCT number: NCT00527761
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: August 2004
• Completion date: November 2007