Spots Global Cancer Trial Database for Radiation Therapy Plus Paclitaxel and Cisplatin in Treating Patients With Cervical Cancer
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Trial Identification
Brief Title: Radiation Therapy Plus Paclitaxel and Cisplatin in Treating Patients With Cervical Cancer
Official Title: 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
Study ID: NCT00003379
Conditions
Study Description
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more sensitive to radiation. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy to the pelvis plus paclitaxel and cisplatin in treating patients who have cervical cancer.
Detailed Description: OBJECTIVES: * 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 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
CCOP - Western Regional, Arizona, Phoenix, Arizona, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Saint Joseph Regional Medical Center, South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
CCOP - Kansas City, Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Cooper University Hospital, Camden, New Jersey, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States
Southeast Gynecologic Oncology Associates, Knoxville, Tennessee, United States
Gynecologic Oncology Network, Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Contact Details
Name: Joan L. Walker, MD
Affiliation: Oklahoma University Cancer Institute
Role: STUDY_CHAIR
Name: Michael L. Pearl, MD
Affiliation: Stony Brook University
Role:
Name: Ming-teh D. Chen, MD
Affiliation: Women's Cancer Center - Los Gatos
Role:
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