- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85006-2726
- CCOP - Western Regional, Arizona
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Delaware
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Newark, Delaware, United States, 19713
- CCOP - Christiana Care Health Services
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Illinois
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Chicago, Illinois, United States, 60612
- MBCCOP - University of Illinois at Chicago
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Decatur, Illinois, United States, 62794-9640
- CCOP - Central Illinois
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Evanston, Illinois, United States, 60201
- CCOP - Evanston
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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South Bend, Indiana, United States, 46617
- Saint Joseph Regional Medical Center
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Iowa
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Iowa City, Iowa, United States, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Maryland
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Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Michigan
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Ann Arbor, Michigan, United States, 48106
- CCOP - Michigan Cancer Research Consortium
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Grand Rapids, Michigan, United States, 49503
- CCOP - Grand Rapids
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Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
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Minnesota
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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Mississippi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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Springfield, Missouri, United States, 65807
- CCOP - Cancer Research for the Ozarks
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Nebraska
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Omaha, Nebraska, United States, 68106
- CCOP - Missouri Valley Cancer Consortium
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New Jersey
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Camden, New Jersey, United States, 08103-1489
- Cooper University Hospital
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Winston-Salem, North Carolina, United States, 27157-1065
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cleveland, Ohio, United States, 44106
- Ireland Cancer Center
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Cleveland, Ohio, United States, 44124
- Cleveland Clinic Taussig Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73190
- University of Oklahoma College of Medicine
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Oregon
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Portland, Oregon, United States, 97225
- CCOP - Columbia River Oncology Program
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Pittsburgh, Pennsylvania, United States, 15213-3180
- UPMC Cancer Center at Magee-Womens Hospital
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Tennessee
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Knoxville, Tennessee, United States, 37917
- Southeast Gynecologic Oncology Associates
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Nashville, Tennessee, United States, 37203
- Gynecologic Oncology Network
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Nashville, Tennessee, United States, 37232-2516
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
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Texas
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Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically proven stage IB2, IIA, IIB, IIIB, or IVA invasive carcinoma of the uterine cervix
- Any cell type
- No metastases to para-aortic lymph nodes, scalene nodes, or to other organs outside the radiation field at time of original staging
- Study entry required within 8 weeks of diagnosis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- GOG 0-2
Life expectancy:
- More than 6 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 3 times normal
Renal:
- Creatinine less than 2.0 mg/dL
- No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) that would require modification of radiation fields
Other:
- Not pregnant
- No septicemia or severe infection
- No other invasive malignancy within the past 3 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy
Chemotherapy:
- No prior chemotherapy for this or any prior malignancy
Endocrine therapy:
- No prior endocrine therapy
Radiotherapy:
- No prior pelvic or abdominal radiotherapy for this malignancy
- No prior radiotherapy for any other prior malignancy
- No more than 1 month interval between surgery and radiotherapy
Surgery:
- See Radiotherapy
Other:
- No other prior therapy for this malignancy
- Stent or nephrostomy tube required if ureteral obstruction present
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Joan L. Walker, MD, Oklahoma University Cancer Institute
- Michael L. Pearl, MD, Stony Brook University
- Ming-teh D. Chen, MD, Women's Cancer Center - Los Gatos
Publications and helpful links
General Publications
- DiSilvestro PA, Walker JL, Morrison A, Rose PG, Homesley H, Warshal D; Gynecologic Oncology Group. Radiation therapy with concomitant paclitaxel and cisplatin chemotherapy in cervical carcinoma limited to the pelvis: a phase I/II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Dec;103(3):1038-42. doi: 10.1016/j.ygyno.2006.06.017. Epub 2006 Aug 4.
- Walker J, Morrison A, DiSilvestro P, et al.: GOG protocol 9803: phase I evaluation of the treatment of invasive cervical cancer confined to the pelvis with combination of radiation and weekly cisplatin and paclitaxel. [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-157, 46, 2004.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Uterine Cervical Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
Other Study ID Numbers
- CDR0000066374
- GOG-9803
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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