Clinical Trial: Radiation Therapy Plus Paclitaxel and Cisplatin in Treating Patients With Cervical Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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

MedlinePlus related topics:  Cervical Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of Radiotherapy Combined With Paclitaxel and Cisplatin in Patients With Stage IB2, IIA, IIB, IIIB, or IVA Invasive Carcinoma of the Cervix

Further Study Details: 

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.

Eligibility

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:

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • No prior biologic therapy

Chemotherapy:

Endocrine therapy:

  • No prior endocrine therapy

Radiotherapy:

Surgery:

  • See Radiotherapy

Other:

  • No other prior therapy for this malignancy
  • Stent or nephrostomy tube required if ureteral obstruction present

Location Information


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   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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