Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004005
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
1999-11-01
Brief Title:
Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma Cancer Other Refractory Carcinoma or Metastatic Adenoma Cancer of Unknown Primary Origin
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Irinotecan and 5-FluorouracilLeucovorin for Patients With Colorectal Carcinoma and Other Refractory Tumors
Status:
COMPLETED
Status Verified Date:
2011-10
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 such as irinotecan fluorouracil and leucovorin work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III or stage IV colorectal carcinoma cancer other refractory carcinoma cancer or metastatic adenocarcinoma cancer of unknown primary origin
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III or stage IV colorectal carcinoma cancer other refractory carcinoma cancer or metastatic adenocarcinoma cancer of unknown primary origin
Detailed Description:
OBJECTIVES
Determine the response rate in patients with stage IV colorectal carcinoma or other carcinomas treated with irinotecan followed by fluorouracil and leucovorin calcium
Determine the disease-free survival of patients with stage III colorectal carcinoma other refractory carcinomas or metastatic adenocarcinomas of unknown primary site treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE Patients with stage III colorectal carcinoma post surgical resection receive irinotecan IV over 1 hour on days 1-5 and days 8-12 Treatment repeats every 3 weeks for 2 courses Beginning on week 7 patients receive pelvic irradiation leucovorin calcium IV over 4 hours and fluorouracil IV over 5-15 minutes beginning 1 hour into leucovorin calcium infusion on days 1-5 Treatment repeats every 3 weeks for a total of 2 courses Patients with no evidence of disease may repeat the above 12-week block of chemotherapy without pelvic irradiation up to 4 times over 1 year
Patients with stage IV colorectal carcinoma other refractory carcinomas or metastatic adenocarcinomas of unknown primary site receive the above 12-week block of chemotherapy irinotecan fluorouracil and leucovorin calcium with pelvic irradiation if indicated Pelvic irradiation patients with an unresected primary tumor undergo exploratory surgery 4-5 weeks after completion of radiotherapy even in the absence of visible tumor regression Radical resection is attempted to effect local control and control of long term symptoms related to the primary tumor Patients with complete response CR or partial response PR after both chemotherapy and surgery repeat the above 12-week block of chemotherapy 3 times over 1 year in the absence of disease progression or unacceptable toxicity Patients with CR or PR after chemotherapy but no response after surgery receive irinotecan IV over 1 hour on days 1-5 and days 8-12 every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity Patients with stable disease SD or progressive disease after 2 courses of irinotecan and SD CR or PR after surgery receive leucovorin calcium and fluorouracil as above every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 4 years
Determine the response rate in patients with stage IV colorectal carcinoma or other carcinomas treated with irinotecan followed by fluorouracil and leucovorin calcium
Determine the disease-free survival of patients with stage III colorectal carcinoma other refractory carcinomas or metastatic adenocarcinomas of unknown primary site treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE Patients with stage III colorectal carcinoma post surgical resection receive irinotecan IV over 1 hour on days 1-5 and days 8-12 Treatment repeats every 3 weeks for 2 courses Beginning on week 7 patients receive pelvic irradiation leucovorin calcium IV over 4 hours and fluorouracil IV over 5-15 minutes beginning 1 hour into leucovorin calcium infusion on days 1-5 Treatment repeats every 3 weeks for a total of 2 courses Patients with no evidence of disease may repeat the above 12-week block of chemotherapy without pelvic irradiation up to 4 times over 1 year
Patients with stage IV colorectal carcinoma other refractory carcinomas or metastatic adenocarcinomas of unknown primary site receive the above 12-week block of chemotherapy irinotecan fluorouracil and leucovorin calcium with pelvic irradiation if indicated Pelvic irradiation patients with an unresected primary tumor undergo exploratory surgery 4-5 weeks after completion of radiotherapy even in the absence of visible tumor regression Radical resection is attempted to effect local control and control of long term symptoms related to the primary tumor Patients with complete response CR or partial response PR after both chemotherapy and surgery repeat the above 12-week block of chemotherapy 3 times over 1 year in the absence of disease progression or unacceptable toxicity Patients with CR or PR after chemotherapy but no response after surgery receive irinotecan IV over 1 hour on days 1-5 and days 8-12 every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity Patients with stable disease SD or progressive disease after 2 courses of irinotecan and SD CR or PR after surgery receive leucovorin calcium and fluorouracil as above every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-G99-1554 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA021765 |
| P30CA021765 | NIH | None | None |
| SJCRH-CACO5 | None | None | None |