Cervical Cancer Clinical Trial
Official title:
A Phase I/II Study of Docetaxel as a Radiosensitizer for Locally Advanced Cervical Cancer (GIA 13026)
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells.
Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel
together with radiation therapy 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 radiation therapy and to see how well they work in treating patients
with stage II, stage III, or stage IV cervical cancer.
OBJECTIVES:
Primary
- 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)
Secondary
- Determine the safety, feasibility, and toxicity of this regimen in these patients.
(Phase I)
- 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
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