A Phase I/II Study of Docetaxel as a Radiosensitizer for Locally Advanced Cervical Cancer (GIA 13026)
- Determine the recommended phase II dose (RPTD) of docetaxel when administered with
radiotherapy in patients with stage IIB-IVA cervical cancer. (Phase I)
- Assess the progression-free survival of patients treated with this regimen. (Phase II)
- Determine the safety, feasibility, and toxicity of this regimen in these patients.
- Assess the toxicity of this regimen at the RPTD in these patients. (Phase II)
- Determine the response in patients treated with this regimen. (Phase II)
OUTLINE: This is a phase I, nonrandomized, prospective, dose-escalation study of docetaxel
followed by an open-label phase II study.
- Phase I: Patients receive docetaxel IV over 30 minutes on day 1. Treatment repeats
weekly for up to 6 courses in the absence of disease progression or unacceptable
toxicity. Patients also undergo concurrent pelvic external-beam radiotherapy (EBRT)
once daily 5 days a week for 5 weeks. Beginning 1-2 weeks after completion of EBRT,
patients receive one or two applications of intracavitary low-dose-rate brachytherapy
(LDR BT) comprising cesium-137.
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. The recommended phase II dose (RPTD) is the
dose below the MTD.
- Phase II: Patients receive docetaxel at the RPTD, EBRT, and LDR BT as in phase I.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Recommended phase II dose (Phase I)
Joseph A. Lucci, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Miami Sylvester Comprehensive Cancer Center||Miami, Florida 33136|