Clinical trial NCT00388154
Conditions: Endometrial Cancer
Keywords: Endometrial Cancer Gemcitabine Gemzar Gemcitabine Hydrochloride Cisplatin Platinol-AQ Platinol CDDP
Sponsor: M.D. Anderson Cancer Center
Start date: 2004-08-01; Completion date: 2013-11-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

* To estimate the antitumor activity of the combination of gemcitabine and cisplatin in patients with advanced (stage III or IV) or recurrent endometrial cancer.

Secondary Objective:

* To determine the nature and degree of toxicity of the combination of gemcitabine and cisplatin in this cohort of patients.

Detailed description:
Gemcitabine and cisplatin are drugs that are used in the treatment of many types of cancer. Each acts to kill cancer cells throughout the body.

Before treatment starts, you will have a complete physical exam, pelvic exam, blood tests (about 2-3 teaspoons), a chest x-ray, and a CT scan or MRI. Women able to have children must have a negative blood pregnancy test.

On Day 1 and Day 8, you will receive gemcitabine chemotherapy through a small tube placed in a vein over 1 hour. This will be followed by cisplatin chemotherapy given by vein over 1 hour. Before chemotherapy is given, you will receive medications to prevent nausea. You will not receive any therapy on Day 15. One course of therapy is 3 weeks long.

Routine blood tests (about 1 teaspoon) will be done weekly during treatment and before each course of therapy (every 3 weeks). A complete checkup, including a history and physical exam, pelvic exam, and routine blood tests (about 2-3 teaspoons) will also be done before each course of therapy and a month after treatment ends. CT or MRI scans will be repeated every 2 to 3 cycles and at the end of treatment. Participants who have a partial or complete response (the tumor shrinks by more than 50% or disappears completely) will have the CT or MRI repeated at least 4 weeks later to confirm the response.

You may continue to receive treatment as long as your disease remains stable or improves. Participants who experience significant side effects may be allowed to drop to a lower dose if their disease is not worse. If the disease gets worse or if intolerable side effects occur, you will be taken off study.

When you are taken off the study, a complete medical history and physical exam will be performed. Routine blood tests (about 2-3 teaspoons) will be performed. Any side effects will be monitored until they go away.

This is an investigational study. Both of the study drugs are FDA approved and commercially available, though their use together in this study is investigational. Up to 35 patients will take part in this study. Patients will be enrolled at M.D. Anderson, St. Lukes Episcopal Hospital and The Woman's Hospital of Texas.

Arms: arm 1: Gemcitabine 900 mg/m\^2 by vein (IV) over 1 hour on Day 1 and Day 8. Cisplatin 30 mg/m\^2 by vein over 1 hour on Day 1 and Day 8.
Interventions: intervention 1: Gemcitabine intervention 2: Cisplatin
Intervention descriptions: intervention 1: 900 mg/m\^2 by vein over 1 hour on Day 1 and Day 8. intervention 2: 30 mg/m\^2 by vein over 1 hour on Day 1 and Day 8.

Protocol documents: