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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-9803 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| paclitaxel | Drug | |||
| brachytherapy | Radiation | |||
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
Histologically proven stage IB2, IIA, IIB, IIIB, or IVA invasive carcinoma of the uterine cervix
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Joan L. Walker, MD | Oklahoma University Cancer Institute | Study Chair |
| Michael L. Pearl, MD | Stony Brook University | |
| Ming-teh D. Chen, MD | Women's Cancer Center - Los Gatos |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Western Regional, Arizona | Phoenix | Arizona | 85006-2726 | United States | ||
| CCOP - Christiana Care Health Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16889823 | Result | 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. | |
| Result | 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. |
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| Newark |
| Delaware |
| 19713 |
| United States |
| MBCCOP - University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| CCOP - Central Illinois | Decatur | Illinois | 62794-9640 | United States |
| CCOP - Evanston | Evanston | Illinois | 60201 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Saint Joseph Regional Medical Center | South Bend | Indiana | 46617 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland | 20892-1182 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65807 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103-1489 | United States |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1065 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44124 | United States |
| University of Oklahoma College of Medicine | Oklahoma City | Oklahoma | 73190 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| CCOP - Geisinger Clinic and Medical Center | Danville | Pennsylvania | 17822-2001 | United States |
| UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213-3180 | United States |
| Southeast Gynecologic Oncology Associates | Knoxville | Tennessee | 37917 | United States |
| Gynecologic Oncology Network | Nashville | Tennessee | 37203 | United States |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville | Tennessee | 37232-2516 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D001918 | Brachytherapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
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