Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003704
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Radiation Therapy in Treating Patients With Unresectable Residual or Recurrent Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase I Study of Oral Capecitabine Xeloda as a Radiation Enhancer in Locally Unresectable Residual or Recurrent Colorectal Cancer Localized in the Pelvis
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses x-rays to damage tumor cells Drugs such as capecitabine may make the tumor cells more sensitive to radiation therapy
PURPOSE Phase I trial to study the effectiveness of capecitabine in combination with radiation therapy in treating patients who have unresectable residual or recurrent colorectal cancer located in the pelvis
PURPOSE Phase I trial to study the effectiveness of capecitabine in combination with radiation therapy in treating patients who have unresectable residual or recurrent colorectal cancer located in the pelvis
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of oral capecitabine administered in combination with pelvic radiotherapy in patients with unresectable residual or locally recurrent cancer localized in the pelvis II Determine the tolerance of this regimen in these patients III Determine the preliminary evidence of therapeutic acticivity of this regimen in these patients
OUTLINE This is a dose-escalation study of capecitabine Patients receive oral capecitabine twice a day 7 days a week for 6 weeks with concurrent radiotherapy Radiotherapy is initiated on the same day as the initiation of capecitabine and is administered 5 days a week for 55-6 weeks Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is reached The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A maximum of 51 patients will be accrued for this study
OUTLINE This is a dose-escalation study of capecitabine Patients receive oral capecitabine twice a day 7 days a week for 6 weeks with concurrent radiotherapy Radiotherapy is initiated on the same day as the initiation of capecitabine and is administered 5 days a week for 55-6 weeks Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is reached The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A maximum of 51 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000066811 | REGISTRY | PDQ Physician Data Query | None |