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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I Study of Gemcitabine, Doxorubicin, Paclitaxel and Carboplatin in Patients with Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium and Impaired Renal Function

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	MSKCC-97114 NCI-G98-1438, NCT00003342

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

This phase I trial is studying the side effects of giving gemcitabine, doxorubicin, and paclitaxel together with carboplatin in treating patients with advanced bladder or kidney cancer and impaired kidney function.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No previous chemotherapy
• At least 4 weeks since radiation therapy
• No previous radiation therapy to the bladder
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive an infusion of gemcitabine and an infusion of doxorubicin once every other week. Patients will also receive an injection of filgrastim on days 3-10 of each course. Treatment may be repeated for up to 5 courses. One week after the completion of gemcitabine and doxorubicin, they will receive a 1-hour infusion of paclitaxel plus carboplatin once a week for up to 12 weeks. Patients will be evaluated at week 16 and at the completion of treatment.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Dean Bajorin, MD, Protocol chair		Ph: 646-422-4333; 800-525-2225

Registry Information
Official Title		Phase I Trial of Dose-Dense Gemcitabine, Doxorubicin, Then Paclitaxel Plus Carboplatin In Patients With Transitional Cell Carcinoma of the Urothelium and Impaired Renal Function
Trial Start Date		1997-12-23
Registered in ClinicalTrials.gov		NCT00003342
Date Submitted to PDQ		1998-05-22
Information Last Verified		2005-09-19
NCI Grant/Contract Number		P30-CA08748

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