Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix
RATIONALE: Drugs used in chemotherapy, such as cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Drugs such as amifostine may protect normal cells from the side effects of radiation therapy.
PURPOSE: Phase I/II trial to study the effectiveness of combining cisplatin and radiation therapy with or without amifostine in treating patients who have stage IIIB or stage IVA cancer of the cervix.
Drug: amifostine trihydrate
Radiation: radiation therapy
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Two Part Phase I/II Study Of Extended Field External Irradiation And Intracavitary Brachytherapy Combined With Chemotherapy (Weekly Cisplatin-Arm1) And Amifostine (Arm 2) In Carcinoma Of The Cervix With Positive Para-Aortic Or High Common Iliac Lymph Nodes|
- Feasibility and tolerability [ Time Frame: From start of treatment to 90 days ] [ Designated as safety issue: Yes ]
- Toxicity [ Time Frame: From start of treatment to 90 days ] [ Designated as safety issue: Yes ]
- Pelvic tumor control [ Time Frame: From registration to date of pelvic tumor failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. ] [ Designated as safety issue: No ]
- Distant metastases [ Time Frame: From registration to date of distant mets or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. ] [ Designated as safety issue: No ]
|Study Start Date:||August 2001|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Radiation therapy and Chemotherapy (cisplatin)
|Drug: cisplatin Radiation: brachytherapy Radiation: radiation therapy|
Radiation therapy and Chemotherapy (cisplatin) plus Amifostine
|Drug: amifostine trihydrate Drug: cisplatin Radiation: brachytherapy Radiation: radiation therapy|
- Determine the feasibility and tolerability of external beam radiotherapy, brachytherapy, and cisplatin in patients with para-aortic or high common iliac lymph node-positive carcinoma of the uterine cervix.
- Determine the feasibility and tolerability of this regimen with the addition of amifostine in these patients.
- Determine the efficacy of these 2 regimens, in terms of improving pelvic and para-aortic tumor control and distant metastases, in these patients.
- Phase I: Patients undergo external beam radiotherapy to the pelvis and para-aortic region 5 days a week for 5 weeks. Patients also undergo either intracavitary low-dose rate (LDR) brachytherapy in 2 applications beginning within 2 weeks after completion of external beam radiotherapy at 2-3 week intervals or 6 fractions of high-dose rate intracavitary brachytherapy over 8 weeks beginning as early as week 2 of external beam radiotherapy. Patients also receive cisplatin IV over 1 hour weekly for 6 weeks concurrently with external beam radiotherapy and once with LDR brachytherapy. Phase II proceeds only if toxicity in phase I is within expected parameters.
- Phase II: Patients receive external beam radiotherapy, brachytherapy, and cisplatin as in phase I. Patients also receive amifostine subcutaneously daily just before external beam radiotherapy and cisplatin. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40-66 patients (27 for phase I and 13-39 for phase II) will be accrued for this study within 12-30 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00012012
|United States, Florida|
|Baptist Cancer Institute - Jacksonville|
|Jacksonville, Florida, United States, 32207|
|Florida Oncology Associates at Southside Cancer Center|
|Jacksonville, Florida, United States, 32207|
|Integrated Community Oncology Network|
|Jacksonville Beach, Florida, United States, 32250|
|Baptist Medical Center South|
|Jascksonville, Florida, United States, 32258|
|Florida Oncology Associates|
|Orange Park, Florida, United States, 32073|
|Florida Cancer Center - Palatka|
|Palatka, Florida, United States, 32177|
|Flagler Cancer Center|
|Saint Augustine, Florida, United States, 32086|
|United States, Michigan|
|West Michigan Cancer Center|
|Kalamazoo, Michigan, United States, 49007-3731|
|Bronson Methodist Hospital|
|Kalamazoo, Michigan, United States, 49007|
|Borgess Medical Center|
|Kalamazooaa, Michigan, United States, 49001|
|United States, Nevada|
|University Medical Center of Southern Nevada|
|Las Vegas, Nevada, United States, 89102|
|CCOP - Nevada Cancer Research Foundation|
|Las Vegas, Nevada, United States, 89106|
|United States, New Jersey|
|Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton|
|Marlton, New Jersey, United States, 08053|
|Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare|
|Vineland, New Jersey, United States, 08360|
|United States, Ohio|
|Akron City Hospital|
|Akron, Ohio, United States, 44309-2090|
|Cancer Treatment Center|
|Wooster, Ohio, United States, 44691|
|United States, Pennsylvania|
|Mercy Cancer Institute at Mercy Hospital|
|Pittsburgh, Pennsylvania, United States, 15219|
|Study Chair:||William Small, MD||Robert H. Lurie Cancer Center|