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Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer
This study has been completed.
Study NCT00041093   Information provided by National Cancer Institute (NCI)
First Received: July 8, 2002   Last Updated: July 23, 2008   History of Changes

July 8, 2002
July 23, 2008
June 2002
January 2008   (final data collection date for primary outcome measure)
Response rate by GOG RECIST criteria every 8 weeks [ Designated as safety issue: No ]
Response rate by GOG RECIST criteria every 8 weeks
Complete list of historical versions of study NCT00041093 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Frequency and severity of adverse events by NCI CTC v2.0 every 4 weeks
  • Overall survival
  • Duration of progression-free interval
 
Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer
A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

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.

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.

Phase II
Interventional
Treatment
Cervical Cancer
Drug: docetaxel
 
Garcia AA, Blessing JA, Vaccarello L, Roman LD; Gynecologic Oncology Group Study. Phase II clinical trial of docetaxel in refractory squamous cell carcinoma of the cervix: a Gynecologic Oncology Group Study. Am J Clin Oncol. 2007 Aug;30(4):428-31.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
January 2008   (final data collection date for primary outcome measure)

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
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00041093
 
CDR0000069442, GOG-0127S
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Agustin Garcia, MD Cedars-Sinai Medical Center
National Cancer Institute (NCI)
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP