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	Treatment or Intervention	Phase
Cervical Cancer	Drug: cisplatin  Drug: paclitaxel  Procedure: brachytherapy  Procedure: chemotherapy  Procedure: radiation therapy  Procedure: radiosensitization	Phase I Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States
Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Central Illinois, Decatur,  Illinois,  62794-9640,  United States
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States
      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States
      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States
Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1002,  United States
Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States
Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States
New Jersey
      Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1065,  United States
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States
Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44124,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106,  United States
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States
Pennsylvania
      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
Tennessee
      Gynecologic Oncology Network, Nashville,  Tennessee,  37203,  United States
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States

Study chairs or principal investigators

Joan L. Walker, MD,  Study Chair,  Oklahoma University Medical Center   
Michael L. Pearl, MD,  Long Island Cancer Center at Stony Brook University Hospital   
M. Dwight Chen, MD,  Women's Cancer Center at Community Hospital of Los Gatos   

Study ID Numbers:  CDR0000066374; GOG-9803
Record last reviewed:  December 2004
Last Updated:  December 9, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003379
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08