Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003344
Status:
COMPLETED
Last Update Posted:
2018-05-16
First Post:
1999-11-01
Brief Title:
Radiation Therapy Plus Irinotecan in Treating Patients With Colon Cancer
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Phase I-II Study of Weekly CPT-11 and Radiation Therapy for Unresectable or Locally Recurrent Large Bowel Cancer
Status:
COMPLETED
Status Verified Date:
2018-05
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 Radiation therapy uses high energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of radiation therapy plus irinotecan in treating patients with colon cancer that is recurrent or that cannot be removed surgically
PURPOSE Phase III trial to study the effectiveness of radiation therapy plus irinotecan in treating patients with colon cancer that is recurrent or that cannot be removed surgically
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD of weekly irinotecan that will result in an acceptable level of toxicity when given in combination with concurrent external beam radiation therapy II Determine the objective response rate of these patients at the dose level below the MTD
OUTLINE Patients receive irinotecan IV over 90 minutes beginning within 24 hours of radiotherapy on days 1 8 15 and 22 External beam radiotherapy is administered 5 days per week for 55-6 weeks starting on day 1 concurrent with chemotherapy Cohorts of 3-6 patients are treated until the maximum tolerated dose MTD has been determined The MTD is defined as the dose level at which the incidence of dose limiting toxicity is no greater than one-third of the patients treated at that dose level Once the MTD has been determined additional patients receive irinotecan at the dose level below the MTD with external beam radiation therapy on the same treatment schedule as above Patients are followed at 4 weeks after treatment then every 3 months for 2 years and then every 6 months for 3 additional years
PROJECTED ACCRUAL Approximately 3-24 patients will be accrued into the Phase I portion of this study Approximately 15-25 patients will be accrued into the Phase II portion of this study
OUTLINE Patients receive irinotecan IV over 90 minutes beginning within 24 hours of radiotherapy on days 1 8 15 and 22 External beam radiotherapy is administered 5 days per week for 55-6 weeks starting on day 1 concurrent with chemotherapy Cohorts of 3-6 patients are treated until the maximum tolerated dose MTD has been determined The MTD is defined as the dose level at which the incidence of dose limiting toxicity is no greater than one-third of the patients treated at that dose level Once the MTD has been determined additional patients receive irinotecan at the dose level below the MTD with external beam radiation therapy on the same treatment schedule as above Patients are followed at 4 weeks after treatment then every 3 months for 2 years and then every 6 months for 3 additional years
PROJECTED ACCRUAL Approximately 3-24 patients will be accrued into the Phase I portion of this study Approximately 15-25 patients will be accrued into the Phase II portion of 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 |
|---|---|---|---|
| NCI-V98-1420 | None | None | None |
| MUSC-7532 | None | None | None |
| HCCMUSC-GI-01 | None | None | None |