Phase I Study of Capecitabine (Xeloda) and Radiation Therapy in Patients With Locally Advanced Cervical and Pelvic Malignancies
OBJECTIVES:
Primary
- 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.
Secondary
- 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
toxicity.
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
MTD.
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
months.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
weekly
Yes
Charles Kunos, MD, PhD
Principal Investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
CASE9804
NCT00118300
April 2005
Name | Location |
---|---|
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 |