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Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00041093
Collaborator
National Cancer Institute (NCI) (NIH)
27
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PRIMARY OBJECTIVES:

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

  2. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Jun 1, 2002
Actual Primary Completion Date :
Oct 23, 2006

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Duration of progression-free interval [5 years]

    2. Frequency and duration of objective response as assessed on radiologic scan [5 years]

    3. Frequency and severity of observed adverse effects [5 years]

    4. Survival time [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gynecologic Oncology Group Philadelphia Pennsylvania United States 19103

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Agustin Garcia, Gynecologic Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gynecologic Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00041093
    Other Study ID Numbers:
    • GOG-0127S
    • NCI-2012-02476
    • CDR0000069442
    • GOG-0127S
    • GOG-0127S
    • U10CA027469
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jan 10, 2018
    Last Verified:
    Jan 1, 2018
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Recurrence
    Docetaxel

    Study Results

    No Results Posted as of Jan 10, 2018