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Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer
This study has been completed.
First Received: July 8, 2002   Last Updated: July 23, 2008   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00041093
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have persistent or recurrent cervical cancer.


Condition Intervention Phase
Cervical Cancer
Drug: docetaxel
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate by GOG RECIST criteria every 8 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and severity of adverse events by NCI CTC v2.0 every 4 weeks [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • Duration of progression-free interval [ Designated as safety issue: No ]

Study Start Date: June 2002
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of docetaxel in patients with persistent or recurrent squamous cell carcinoma of the cervix.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within at least 6-7 months.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed persistent or recurrent squamous cell carcinoma of the cervix
  • Progressive disease
  • At least 1 unidimensionally measurable target lesion

    • At least 20 mm by conventional techniques OR
    • At least 10 mm by spiral CT scan
    • Tumors within a previously irradiated field are not considered target lesions
  • One prior systemic chemotherapeutic regimen for advanced, metastatic, or recurrent squamous cell carcinoma of the cervix required

    • Chemotherapy administered as a radiosensitizer in conjunction with primary radiotherapy is not considered a systemic chemotherapy regimen
  • Ineligible for a higher priority GOG protocol (e.g., any active Phase III GOG protocol or GOG-0076)

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No congestive heart failure
  • No unstable angina, myocardial infarction, or new cardiac arrhythmia within the past 6 months

Other:

  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics
  • No greater than grade 1 sensory and motor neuropathy
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior biologic or immunologic therapy directed at malignant tumor
  • One prior noncytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) for recurrent or persistent disease allowed

Chemotherapy:

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No prior docetaxel
  • No more than 1 prior cytotoxic chemotherapy regimen

Endocrine therapy:

  • At least one week since prior hormonal therapy directed at malignant tumor
  • Concurrent hormone replacement therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery:

  • Recovered from recent prior surgery

Other:

  • At least 3 weeks since any prior therapy directed at malignant tumor
  • No prior anticancer therapy that would preclude study
  • No concurrent amifostine or other protective agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041093

  Hide Study Locations
Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1740
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80010
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Central Illinois
Decatur, Illinois, United States, 62794-9640
CCOP - Evanston
Evanston, Illinois, United States, 60201
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Massachusetts
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01605-2982
United States, Michigan
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Mississippi
Keesler Medical Center - Keesler Air Force Base
Keesler AFB, Mississippi, United States, 39534-2576
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0520
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213-3180
United States, Tennessee
Southeast Gynecologic Oncology Associates
Knoxville, Tennessee, United States, 37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-2516
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Agustin Garcia, MD Cedars-Sinai Medical Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000069442, GOG-0127S
Study First Received: July 8, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00041093     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent cervical cancer
cervical squamous cell carcinoma

Additional relevant MeSH terms:
Docetaxel
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Pharmacologic Actions
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 27, 2009