A Phase I/II Study Of Whole Pelvic Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis
- Determine the toxicity of radiotherapy plus paclitaxel and cisplatin used as
radiosensitization in patients with stage IB2, IIA, IIB, IIIB, or IVA invasive
carcinoma of the cervix.
- Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus
radiotherapy in these patients.
- Determine the effects of this regimen at the maximum tolerated dose on progression-free
survival and overall survival in these patients.
- Determine the site of local or distant recurrence in these patients after treatment
with this regimen.
OUTLINE: This is a dose escalation study of paclitaxel.
Patients undergo external beam radiotherapy (RT) to the pelvic region 5 days a week during
weeks 1-5. Patients receive paclitaxel IV over 1 hour immediately followed by cisplatin
concurrently with pelvic field radiotherapy on days 1, 8, 15, 22, 29, and 36. Patients
undergo low-dose rate (LDR) OR high-dose rate (HDR) brachytherapy. For patients undergoing
LDR brachytherapy, intracavitary implants are inserted 1 or 2 times within 3 weeks after
completion of external beam RT. For patients undergoing HDR brachytherapy, intracavitary
implants are inserted once a week for 5 weeks beginning during week 4 of external beam RT.
Patients may receive a parametrial boost.
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional
patients are accrued and treated at the MTD as above.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter or at time of recurrence until death.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3-7
Primary Purpose: Treatment
Joan L. Walker, MD
Oklahoma University Cancer Institute
United States: Federal Government
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|University of Mississippi Medical Center||Jackson, Mississippi 39216-4505|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|University of Oklahoma College of Medicine||Oklahoma City, Oklahoma 73190|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Cancer Research for the Ozarks||Springfield, Missouri 65807|
|CCOP - Western Regional, Arizona||Phoenix, Arizona 85006-2726|
|MBCCOP - University of Illinois at Chicago||Chicago, Illinois 60612|
|CCOP - Evanston||Evanston, Illinois 60201|
|Saint Joseph Regional Medical Center||South Bend, Indiana 46617|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|CCOP - Grand Rapids||Grand Rapids, Michigan 49503|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|CCOP - Columbia River Oncology Program||Portland, Oregon 97225|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|UPMC Cancer Center at Magee-Womens Hospital||Pittsburgh, Pennsylvania 15213-3180|
|Southeast Gynecologic Oncology Associates||Knoxville, Tennessee 37917|
|Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center||Nashville, Tennessee 37232-2516|
|CCOP - Scott and White Hospital||Temple, Texas 76508|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Cooper University Hospital||Camden, New Jersey 08103|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|Gynecologic Oncology Network||Nashville, Tennessee 37203|