Radiation Therapy Plus Paclitaxel and Cisplatin in Treating Patients With Cervical Cancer
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.
|Cervical Cancer||Drug: cisplatin Drug: paclitaxel Radiation: brachytherapy Radiation: radiation therapy||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|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 Start Date:||November 1999|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003379
Show 31 Study Locations
|Study Chair:||Joan L. Walker, MD||Oklahoma University Cancer Institute|
|OverallOfficial:||Michael L. Pearl, MD||Stony Brook University|
|OverallOfficial:||Ming-teh D. Chen, MD||Women's Cancer Center - Los Gatos|