Phase I Study of Capecitabine (Xeloda) and Radiation Therapy in Patients With Locally Advanced Cervical and Pelvic Malignancies
- Determine the maximum tolerated dose and dose-limiting toxicity of capecitabine when
given in combination with pelvic external beam radiotherapy and intracavitary
brachytherapy in patients with primary or recurrent locally advanced cervical cancer or
other pelvic malignancy.
- Determine the clinical anti-tumor response in patients treated with this regimen.
- Determine adverse clinical sequelae in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of capecitabine.
Patients undergo external beam radiotherapy to the whole pelvis once daily 5 days a week in
weeks 1-5 and receive 1 or 2 applications of low-dose rate intracavitary brachytherapy in
weeks 7-8 OR 5 applications of high-dose rate (HDR)* intracavitary brachytherapy once weekly
in weeks 4-8. Patients also receive oral capecitabine twice daily 7 days a week in weeks 1-5
and 7-8. Courses repeat every 12 weeks in the absence of disease progression or unacceptable
NOTE: *No external beam radiotherapy is administered on the day of HDR brachytherapy. If the
majority of external beam radiotherapy has been administered, HDR brachytherapy may be
administered in 2 applications per week (separated by at least 72 hours) in order to
complete all treatment by week 8.
Cohorts of 3-6 patients receive escalating doses of capecitabine 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. A minimum of 6 patients are treated at the
After completion of study treatment, patients are followed at 1 month, every 3 months for 1
year, every 6 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: Approximately 4-24 patients will be accrued for this study within 2-12
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
Charles Kunos, MD, PhD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|