Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining cisplatin with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy and cisplatin in treating patients with cervical cancer that has not spread beyond the pelvis.
Drug: gemcitabine hydrochloride
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||December 2003|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
- 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 regimen.
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 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068549
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Louisiana|
|Ochsner Cancer Institute at Ochsner Clinic Foundation|
|New Orleans, Louisiana, United States, 70121|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, New Jersey|
|Cancer Institute of New Jersey at Cooper - Voorhees|
|Voorhees, New Jersey, United States, 08043|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|MetroHealth's Cancer Care Center at MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|Lake/University Ireland Cancer Center|
|Mentor, Ohio, United States, 44060|
|United States, Oklahoma|
|Oklahoma University Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Cancer Care Associates - Midtown Tulsa|
|Tulsa, Oklahoma, United States, 74104|
|Study Chair:||Peter G. Rose, MD||MetroHealth Cancer Care Center at MetroHealth Medical Center|