Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

Completed · Phase 2

Conditions studied: Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Recurrent Cervical Carcinoma

In brief

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.

Key facts

Study ID

NCT00041093

Run by

Gynecologic Oncology Group

People needed

27

Starts

2002-06-01

Last updated by the study team

2018-01-10

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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