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Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group Identifier:
First received: July 8, 2002
Last updated: December 7, 2016
Last verified: December 2016
Phase II trial to study the effectiveness of docetaxel in treating patients who have persistent or recurrent cervical cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Condition Intervention Phase
Cervical Squamous Cell Carcinoma, Not Otherwise Specified
Recurrent Cervical Carcinoma
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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 Gynecologic Oncology Group:

Primary Outcome Measures:
  • Duration of progression-free interval [ Time Frame: 5 years ]
  • Frequency and duration of objective response as assessed on radiologic scan [ Time Frame: 5 years ]
  • Frequency and severity of observed adverse effects [ Time Frame: 5 years ]
  • Survival time [ Time Frame: 5 years ]

Enrollment: 27
Study Start Date: June 2002
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (docetaxel)
Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Docetaxel
Given IV
Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate

Detailed Description:


I. Determine the antitumor activity of docetaxel in patients with persistent or recurrent squamous cell carcinoma of the cervix.

II. 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
    • 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)
  • Performance status - GOG 0-2
  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • 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
  • Creatinine no greater than 1.5 times ULN
  • No congestive heart failure
  • No unstable angina, myocardial infarction, or new cardiac arrhythmia within the past 6 months
  • 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
  • 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
  • Recovered from prior chemotherapy
  • No prior docetaxel
  • No more than 1 prior cytotoxic chemotherapy regimen
  • At least one week since prior hormonal therapy directed at malignant tumor
  • Concurrent hormone replacement therapy allowed
  • Recovered from prior radiotherapy
  • Recovered from recent prior surgery
  • 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
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Please refer to this study by its identifier: NCT00041093

United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Agustin Garcia Gynecologic Oncology Group
  More Information

Responsible Party: Gynecologic Oncology Group Identifier: NCT00041093     History of Changes
Other Study ID Numbers: GOG-0127S
NCI-2012-02476 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0127S ( Other Identifier: Gynecologic Oncology Group )
GOG-0127S ( Other Identifier: CTEP )
U10CA027469 ( US NIH Grant/Contract Award Number )
Study First Received: July 8, 2002
Last Updated: December 7, 2016

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2017