Cervical Cancer Clinical Trial
Official title:
Weekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix: A Phase I/II Study
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different
ways to stop tumor cells from dividing so they stop growing or die. Combining docetaxel with
carboplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when
given together with carboplatin and to see how well they work in treating patients with
recurrent stage IVB squamous cell carcinoma (cancer) of the cervix.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of docetaxel when administered with carboplatin in
patients with recurrent stage IVB squamous cell carcinoma of the cervix.
- Determine the response rate and time to progression in patients treated with this
regimen.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is phase I, dose-escalation study of docetaxel followed by a phase II study.
- Phase I: Patients receive docetaxel IV over 30 minutes and carboplatin IV over 30
minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in
the absence of disease progression or unacceptable toxicity. Patients who demonstrate
continuing tumor shrinkage after 6 courses receive 2 additional courses beyond their
best response.
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive docetaxel and carboplatin as in phase I at the MTD determined
in phase I.
Quality of life is assessed at baseline, before every other course of treatment, and at the
end of study treatment.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for phase I and 16-40 for phase II) will be
accrued for this study within 2 years.
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