Trial Information

A Phase I/II Study Of Whole Pelvic Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis

OBJECTIVES:

- Determine the toxicity of radiotherapy plus paclitaxel and cisplatin used as
radiosensitization in patients with stage IB2, IIA, IIB, IIIB, or IVA invasive
carcinoma of the cervix.

- Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus
radiotherapy in these patients.

- Determine the effects of this regimen at the maximum tolerated dose on progression-free
survival and overall survival in these patients.

- Determine the site of local or distant recurrence in these patients after treatment
with this regimen.

OUTLINE: This is a dose escalation study of paclitaxel.

Patients undergo external beam radiotherapy (RT) to the pelvic region 5 days a week during
weeks 1-5. Patients receive paclitaxel IV over 1 hour immediately followed by cisplatin
concurrently with pelvic field radiotherapy on days 1, 8, 15, 22, 29, and 36. Patients
undergo low-dose rate (LDR) OR high-dose rate (HDR) brachytherapy. For patients undergoing
LDR brachytherapy, intracavitary implants are inserted 1 or 2 times within 3 weeks after
completion of external beam RT. For patients undergoing HDR brachytherapy, intracavitary
implants are inserted once a week for 5 weeks beginning during week 4 of external beam RT.
Patients may receive a parametrial boost.

Cohorts of 3-6 patients receive escalating doses of paclitaxel 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. Once the MTD is determined, additional
patients are accrued and treated at the MTD as above.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter or at time of recurrence until death.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3-7
years.