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

Alternate Title

Phase II Study of Neoadjuvant Carboplatin, Paclitaxel, and Gemcitabine Followed By Concurrent Cisplatin and Radiotherapy in Patients With Locally Advanced or Recurrent Carcinoma of the Urothelium

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	SWOG-S0121 S0121, NCT00055835

Trial Description

Purpose:

Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy before radiation therapy, and combining chemotherapy with radiation therapy, may kill more tumor cells.

Phase II trial to study the effectiveness of neoadjuvant gemcitabine, paclitaxel, and carboplatin followed by cisplatin and radiation therapy in treating patients who have locally advanced or recurrent carcinoma (cancer) of the urothelium.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No previous carboplatin, paclitaxel, or gemcitabine.
• No previous radiation therapy to the pelvis
• 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 a 3-hour infusion of paclitaxel and an infusion of carboplatin on day 1. They will also receive an infusion of gemcitabine on days 1 and 8. Treatment may be repeated every 3 weeks for up to three courses. Four to 8 weeks after completing chemotherapy, patients will receive a 30- to 60-minute infusion of cisplatin every 3 weeks for up to two courses. They will also undergo radiation therapy 5 days a week for 6 weeks. Patients will be evaluated every 3 months for 2 years and every 6 months for 3 years.

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

Southwest Oncology Group

Ulka Vaishampayan, MD, Protocol chair		Ph: 313-576-8718; 800-527-6266 Email: vaishamu@karmanos.org

Registry Information
Official Title		Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine followed by Concurrent Cisplatin and Radiation Therapy in Patients with Locally Advanced or Recurrent Urothelial Malignancy
Trial Start Date		2002-11-15
Registered in ClinicalTrials.gov		NCT00055835
Date Submitted to PDQ		2003-01-17
Information Last Verified		2005-04-19
NCI Grant/Contract Number		CA32102

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