Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

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

Intervention / Treatment
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* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (docetaxel)<br>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<br>* Given IV<br>* Other names: Taxotere Injection Concentrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of progression-free interval |  | 5 years | 
| Frequency and duration of objective response as assessed on radiologic scan |  | 5 years | 
| Frequency and severity of observed adverse effects |  | 5 years | 
| Survival time |  | 5 years |