A Phase I Study of Whole Pelvic Radiation Therapy With Concomitant Cisplatin and Gemcitabine Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis
- Determine the toxicity of pelvic radiotherapy and concurrent cisplatin and gemcitabine
in patients with cervical carcinoma limited to the pelvis.
- Determine the maximum tolerated dose (MTD) of gemcitabine in combination with cisplatin
and pelvic radiotherapy in these patients.
- Determine the progression-free and overall survival of patients treated with
gemcitabine at the MTD in this regimen.
- Determine the site of recurrence, local versus distant, in patients treated with this
OUTLINE: This is a multicenter, dose-escalation study of gemcitabine.
Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8,
15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients
also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27,
and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary
radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all
radiotherapy is not more than 8 weeks.
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients
experiences dose-limiting toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-24
Primary Purpose: Treatment
Peter G. Rose, MD
MetroHealth Cancer Care Center at MetroHealth Medical Center
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|MetroHealth's Cancer Care Center at MetroHealth Medical Center||Cleveland, Ohio 44106|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University||Columbus, Ohio 43210-1240|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Lake/University Ireland Cancer Center||Mentor, Ohio 44060|
|Oklahoma University Medical Center||Oklahoma City, Oklahoma 73104|
|Cancer Care Associates - Midtown Tulsa||Tulsa, Oklahoma 74104|
|Ochsner Cancer Institute at Ochsner Clinic Foundation||New Orleans, Louisiana 70121|
|Cancer Institute of New Jersey at Cooper - Voorhees||Voorhees, New Jersey 08043|