ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00003379CDR0000066374GOG-9803NCT00003379Radiation Therapy Plus Paclitaxel and Cisplatin in Treating Patients With Cervical CancerA 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 PelvisGynecologic Oncology GroupOtherNational 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:
- 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.
CompletedNovember 1999January 2007Phase 1/Phase 2InterventionalNoTreatment40Cervical CancerDrugcisplatinDrugpaclitaxelRadiationbrachytherapyRadiationradiation therapy
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
Female18 YearsN/ANoJoan L. Walker, MDStudy ChairOklahoma University Cancer InstituteMichael L. Pearl, MDStony Brook UniversityMing-teh D. Chen, MDWomen's Cancer Center - Los GatosCCOP - Western Regional, ArizonaPhoenixArizona85006-2726United StatesCCOP - Christiana Care Health ServicesNewarkDelaware19713United StatesMBCCOP - University of Illinois at ChicagoChicagoIllinois60612United StatesCCOP - Central IllinoisDecaturIllinois62794-9640United StatesCCOP - EvanstonEvanstonIllinois60201United StatesCCOP - Carle Cancer CenterUrbanaIllinois61801United StatesIndiana University Cancer CenterIndianapolisIndiana46202-5289United StatesSaint Joseph Regional Medical CenterSouth BendIndiana46617United StatesHolden Comprehensive Cancer Center at University of IowaIowa CityIowa52242-1002United StatesWarren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesdaMaryland20892-1182United StatesCCOP - Michigan Cancer Research ConsortiumAnn ArborMichigan48106United StatesCCOP - Grand RapidsGrand RapidsMichigan49503United StatesCCOP - KalamazooKalamazooMichigan49007-3731United StatesCCOP - Metro-MinnesotaSaint Louis ParkMinnesota55416United StatesUniversity of Mississippi Medical CenterJacksonMississippi39216-4505United StatesCCOP - Kansas CityKansas CityMissouri64131United StatesCCOP - Cancer Research for the OzarksSpringfieldMissouri65807United StatesCCOP - Missouri Valley Cancer ConsortiumOmahaNebraska68106United StatesCooper University HospitalCamdenNew Jersey08103-1489United StatesLineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7295United StatesComprehensive Cancer Center at Wake Forest UniversityWinston-SalemNorth Carolina27157-1065United StatesIreland Cancer CenterClevelandOhio44106United StatesCleveland Clinic Taussig Cancer CenterClevelandOhio44124United StatesUniversity of Oklahoma College of MedicineOklahoma CityOklahoma73190United StatesCCOP - Columbia River Oncology ProgramPortlandOregon97225United StatesCCOP - Geisinger Clinic and Medical CenterDanvillePennsylvania17822-2001United StatesUPMC Cancer Center at Magee-Womens HospitalPittsburghPennsylvania15213-3180United StatesSoutheast Gynecologic Oncology AssociatesKnoxvilleTennessee37917United StatesGynecologic Oncology NetworkNashvilleTennessee37203United StatesVanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashvilleTennessee37232-2516United StatesCCOP - Scott and White HospitalTempleTexas76508United StatesUnited StatesDiSilvestro 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 4.16889823Walker 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.November 2004November 1, 1999January 26, 2003January 27, 2003May 24, 2013May 24, 2013May 27, 2013stage III cervical cancerstage IB cervical cancerstage IIB cervical cancerstage IIA cervical cancerstage IVA cervical cancercervical squamous cell carcinomacervical adenocarcinomacervical adenosquamous cell carcinomacervical small cell carcinomaUterine Cervical NeoplasmsPaclitaxelCisplatin