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Radiation Therapy Plus Paclitaxel and Cisplatin in Treating Patients With Cervical Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003379
  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 Intervention Phase
Cervical Cancer
 Drug: cisplatin
Drug: paclitaxel
Radiation: brachytherapy
Radiation: radiation therapy
 Phase I
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Cisplatin Paclitaxel
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: November 1999
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003379

  Show 31 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
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. Epub 2006 Aug 4.
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.

Study ID Numbers: CDR0000066374, GOG-9803
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003379     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III cervical cancer
stage IB cervical cancer
stage IIB cervical cancer
stage IIA cervical cancer
stage IVA cervical cancer
 cervical squamous cell carcinoma
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical small cell carcinoma

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Cisplatin
Antineoplastic Agents
Paclitaxel
Therapeutic Uses
 Mitosis Modulators
Tubulin Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009



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