Weekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix: A Phase I/II Study
- 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
- 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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of docetaxel
Brigitte E. Miller, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|