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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00003379
First received: November 1, 1999
Last updated: May 24, 2013
Last verified: November 2004

November 1, 1999
May 24, 2013
November 1999
January 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003379 on ClinicalTrials.gov Archive Site
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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.

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.

Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
Cervical Cancer
  • Drug: cisplatin
  • Drug: paclitaxel
  • Radiation: brachytherapy
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Not Provided
January 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003379
CDR0000066374, GOG-9803
Not Provided
Not Provided
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Joan L. Walker, MD Oklahoma University Cancer Institute
Investigator: Michael L. Pearl, MD Stony Brook University
Investigator: Ming-teh D. Chen, MD Women's Cancer Center - Los Gatos
Gynecologic Oncology Group
November 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP