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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003379 |
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.
Condition | Intervention | Phase |
---|---|---|
Cervical Cancer |
Drug: cisplatin Drug: paclitaxel Procedure: brachytherapy Procedure: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | 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 |
Estimated Enrollment: | 40 |
Study Start Date: | November 1999 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven stage IB2, IIA, IIB, IIIB, or IVA invasive carcinoma of the uterine cervix
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Joan L. Walker, MD | Oklahoma University Cancer Institute |
Investigator: | Michael L. Pearl, MD | Stony Brook University |
Investigator: | Ming-teh D. Chen, MD | Women's Cancer Center - Los Gatos |
Study ID Numbers: | CDR0000066374, GOG-9803 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003379 |
Health Authority: | United States: Federal Government |
stage III cervical cancer stage IB cervical cancer stage IIB cervical cancer stage IIA cervical cancer stage IVA cervical cancer |
cervical squamous cell carcinoma cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical small cell carcinoma |
Epidermoid carcinoma Carcinoma, Small Cell Cisplatin Paclitaxel Squamous cell carcinoma |
Carcinoma, squamous cell Adenocarcinoma Carcinoma, Squamous Cell Carcinoma, Adenosquamous Carcinoma |
Molecular Mechanisms of Pharmacological Action Radiation-Sensitizing Agents Antineoplastic Agents Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Physiological Effects of Drugs Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |