Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118300
Status:
WITHDRAWN
Last Update Posted:
2011-07-08
First Post:
2005-07-08
Brief Title:
Capecitabine and Radiation Therapy in Treating Patients With Locally Advanced Cervical Cancer or Other Pelvic Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Study of Capecitabine Xeloda and Radiation Therapy in Patients With Locally Advanced Cervical and Pelvic Malignancies
Status:
WITHDRAWN
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Competing studies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as capecitabine 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 Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells Giving chemotherapy together with radiation therapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of capecitabine when given together with radiation therapy in treating patients with locally advanced cervical cancer or other pelvic cancer
PURPOSE This phase I trial is studying the side effects and best dose of capecitabine when given together with radiation therapy in treating patients with locally advanced cervical cancer or other pelvic cancer
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE-9804 | OTHER | None | None |
| CWRU-010514 | Other Identifier | Case Comphrensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |