Cervical Cancer Clinical Trial
Official title:
A Phase I/II Study Of COX-2 Inhibitor, CELEBREX (CELECOXIB), And Chemoradiation In Patients With Locally Advanced Cervical Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. Giving radiation therapy in different ways and combining it with chemotherapy may kill
more tumor cells. Celecoxib may slow the growth of cervical cancer by stopping blood flow to
the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus celecoxib,
fluorouracil, and cisplatin in treating patients who have locally advanced cervical cancer.
OBJECTIVES:
- Determine treatment-related toxicity rates in patients with locally advanced cervical
cancer treated with external beam radiotherapy and brachytherapy concurrently with
celecoxib, fluorouracil, and cisplatin.
- Determine whether this regimen increases locoregional control rates, distant control,
disease-free survival, and overall survival in these patients.
- Determine whether first-failure patterns in patients treated with this regimen are
changed compared to historical controls.
OUTLINE: This is a multicenter study.
Patients undergo external beam pelvic radiotherapy once daily five days a weeks for 5 weeks
beginning on day 1. Within 8 weeks, patients undergo low-dose or high-dose brachytherapy.
Patients also receive concurrent chemotherapy comprising fluorouracil IV continuously over
days 2-5, 23-26, and 44-47 and cisplatin IV over 4 hours on days 1, 22, and 43. Oral
celecoxib is administered twice daily beginning on day 1 and continuing for 12 months.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months
for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1.5 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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