NCT00003379

Radiation Therapy Plus Paclitaxel and Cisplatin in Treating Patients With Cervical Cancer

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	paclitaxel
RADIATION	brachytherapy
RADIATION	radiation therapy

Timeline

• Start date: 1999-11-01
• Primary completion: 2007-01-01
• First posted: 2003-01-27
• Last updated: 2013-05-27

Locations

31 sites across 1 country: United States