Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002801
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE I TRIAL OF POST-OPERATIVE COMBINED ORAL UFT PLUS LEUCOVORIN AND RADIATION THERAPY FOR RECTAL CANCER
Status:
COMPLETED
Status Verified Date:
2009-12
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 Combining more than one drug and combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy consisting of fluorouracil-uracil and leucovorin plus radiation therapy in treating patients with colorectal cancer who have undergone surgery to remove the tumor
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy consisting of fluorouracil-uracil and leucovorin plus radiation therapy in treating patients with colorectal cancer who have undergone surgery to remove the tumor
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose-limiting toxicity of postoperative fluorouracil-uracil plus leucovorin calcium concurrently with radiotherapy in patients with colorectal cancer II Determine the toxicity of this regimen in these patients III Determine the response of tumors in patients with measurable disease treated with this regimen
OUTLINE This is a dose-escalation study of fluorouracil-uracil UFT Beginning within 10 weeks after definitive surgery patients receive oral UFT and oral leucovorin calcium CF 3 times a day on days 1-28 Treatment continues every 5 weeks for 2 courses in the absence of disease progression or unacceptable toxicity Beginning on day 1 of the second course patients undergo radiotherapy to the tumor bed and involved lymph nodes 5 days a week for 5 weeks followed by boost radiotherapy to the primary tumor bed for 5-16 days Patients receive 3 additional courses of UFT plus CF beginning 4 weeks after completion of radiotherapy or after recovery from the toxic effects of UFT whichever occurs later Patients who have measurable disease with ongoing response after the fifth course receive additional courses of UFT and CF Cohorts of 3-6 patients receive escalating doses of UFT during the second course until the maximum tolerated dose MTD is determined The MTD is defined as highest dose at which the minority of patients experience dose-limiting toxicity Patients are followed every 3 months for 1 year and then at the discretion of the investigator
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
OUTLINE This is a dose-escalation study of fluorouracil-uracil UFT Beginning within 10 weeks after definitive surgery patients receive oral UFT and oral leucovorin calcium CF 3 times a day on days 1-28 Treatment continues every 5 weeks for 2 courses in the absence of disease progression or unacceptable toxicity Beginning on day 1 of the second course patients undergo radiotherapy to the tumor bed and involved lymph nodes 5 days a week for 5 weeks followed by boost radiotherapy to the primary tumor bed for 5-16 days Patients receive 3 additional courses of UFT plus CF beginning 4 weeks after completion of radiotherapy or after recovery from the toxic effects of UFT whichever occurs later Patients who have measurable disease with ongoing response after the fifth course receive additional courses of UFT and CF Cohorts of 3-6 patients receive escalating doses of UFT during the second course until the maximum tolerated dose MTD is determined The MTD is defined as highest dose at which the minority of patients experience dose-limiting toxicity Patients are followed every 3 months for 1 year and then at the discretion of the investigator
PROJECTED ACCRUAL Approximately 30 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 |
|---|---|---|---|
| NCI-V96-0942 | None | None | None |
| MSKCC-96025 | None | None | None |
| BMS-MSKCC-96025 | None | None | None |