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

Alternate Title

Phase III Randomized Study of Doxorubicin, Cisplatin, Paclitaxel, and Filgrastim (G-CSF) Versus Carboplatin and Paclitaxel in Patients With Stage III or IV or Recurrent Endometrial Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	GOG-0209 NCT00063999

Special Category: CTSU trial, NCI Web site featured trial

Trial Description

Purpose:

Drugs used in chemotherapy such as doxorubicin, cisplatin, paclitaxel, and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating endometrial cancer.

This randomized phase III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with stage III, stage IV, or recurrent endometrial cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No previous chemotherapy
• At least 4 weeks since radiation therapy to the whole 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 be randomly assigned (have an equal chance of being placed) to one of two groups.

Patients in group one will receive an infusion of doxorubicin and a 1- to 1.5-hour infusion of cisplatin on day 1. They will receive a 3-hour infusion of paclitaxel on day 2 and injections of filgrastim on days 3-12.

Patients in group two will receive a 3-hour infusion of paclitaxel and an infusion of carboplatin on day 1.

Treatment in both groups may be repeated every 3 weeks for up to seven courses. Quality of life will be assessed periodically. Patients will be evaluated every 3 months for 2 years, every 6 months for 3 years, and once a year thereafter.

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

Gynecologic Oncology Group

David Miller, MD, Protocol chair		Ph: 214-648-3026; 866-460-4673 Email: david.miller@utsouthwestern.edu

Related Information

Featured trial article

Registry Information
Official Title		Randomized Phase III Trial Of Doxorubicin/Cisplatin/Paclitaxel And G-CSF Versus Carboplatin/Paclitaxel In Patients With Stage III & IV Or Recurrent Endometrial Cancer
Trial Start Date		2003-08-18
Trial Completion Date		2008-01-24 (estimated)
Registered in ClinicalTrials.gov		NCT00063999
Date Submitted to PDQ		2003-05-14
Information Last Verified		2009-04-21
NCI Grant/Contract Number		CA27469