Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00041093
First received: July 8, 2002
Last updated: February 10, 2016
Last verified: February 2016
  Purpose
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
Recurrent Cervical Carcinoma
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
  • Frequency of objective response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Frequency and severity of observed adverse effects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Survival time [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Duration of objective response [ Time Frame: 5 years ]

Enrollment: 27
Study Start Date: June 2002
Primary Completion Date: January 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:

PRIMARY OBJECTIVES:

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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041093

Locations
United States, Pennsylvania
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
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00041093     History of Changes
Other Study ID Numbers: GOG-0127S  NCI-2012-02476  CDR0000069442  GOG-0127S  GOG-0127S  U10CA027469 
Study First Received: July 8, 2002
Last Updated: February 10, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators

ClinicalTrials.gov processed this record on May 26, 2016