A Phase II Study of Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate (CR + PR)
21-day Cycle Assessments or until either disease progression or adverse effects prohibit further treatment.
Jubilee Brown, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|
|St. Lukes Episcopal Hospital||Houston, Texas 77030|
|The Woman's Hospital of Texas||Houston, Texas 77054|