Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023868
Status:
TERMINATED
Last Update Posted:
2020-12-02
First Post:
2001-09-13
Brief Title:
Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver 6655
Sponsor:
American College of Radiology Imaging Network
Organization:
American College of Radiology Imaging Network
Study Overview
Official Title:
A Randomized Phase IIII Study Of Systematic Chemotherapy With Or Without Hepatic Chemoembolization For Liver-Dominant Metastatic Adenocarcinoma Of The Colon And Rectum
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
redesign
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 the growth of cancer cells either by killing the cells or by stopping the cells from dividing Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor It is not yet known if chemoembolization is more effective than standard chemotherapy in treating metastatic cancer
PURPOSE This phase I trial and randomized phase III trial is studying the effectiveness of chemoembolization in treating patients who have colorectal cancer metastatic to the liver
PURPOSE This phase I trial and randomized phase III trial is studying the effectiveness of chemoembolization in treating patients who have colorectal cancer metastatic to the liver
Detailed Description:
OBJECTIVES
Compare the survival of patients with liver-dominant metastatic colorectal adenocarcinoma treated with irinotecan fluorouracil and leucovorin calcium with or without hepatic chemoembolization
Compare response in the liver time to hepatic tumor progression and time to extrahepatic tumor progression in patients treated with these regimens
Compare the possible treatment differences with respect to morbidity toxic effects of chemoembolization toxic effects of chemotherapy and death from cancer-related complications in these patients
OUTLINE This is a phase I dose-escalation study followed by a phase III randomized multicenter study Phase I closed as of 101402
Phase I Patients in phase I are sequentially enrolled to 1 of 3 treatment regimens Phase I closed as of 101402
Regimen A Patients receive irinotecan IV over 60-90 minutes leucovorin calcium IV and fluorouracil IV over 10 minutes on days 1 8 15 and 22 Patients undergo hepatic embolization with embolic suspension only on day 36
Regimen B Patients receive chemotherapy as in regimen A Patients undergo hepatic chemoembolization with lower-dose cisplatin doxorubicin and mitomycin on day 36
Regimen C Patients receive chemotherapy as in regimen A Patients undergo hepatic chemoembolization with higher-dose cisplatin doxorubicin and mitomycin on day 36
After 1 week of rest patients in all regimens receive a second 4-week course of systemic chemotherapy
Cohorts of 3-10 patients are sequentially enrolled until the maximum tolerated dose MTD of chemotherapy and chemoembolization is determined The MTD is defined as the dose preceding that at which at least 4 of 10 patients experience dose-limiting toxicity
Phase III Patients are stratified according to liver volume involvement less than 25 vs 25-50 vs more than 50 to less than 75 and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive irinotecan IV over 60-90 minutes leucovorin calcium IV and fluorouracil IV over 10 minutes on days 1 8 15 and 22 Courses repeat every 6 weeks in the absence of disease progression
Arm II Patients receive chemotherapy as in arm I Patients undergo hepatic chemoembolization with cisplatin doxorubicin and mitomycin on day 36 Chemotherapy repeats every 6 weeks in the absence of disease progression Chemoembolization may repeat every 6 weeks for 2-4 courses as necessary
Patients in phase III are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 9-18 patients will be accrued for phase I of this study Phase I closed to accrual as of 101402 Approximately 315 patients will be accrued for phase III of this study within 25 years
Compare the survival of patients with liver-dominant metastatic colorectal adenocarcinoma treated with irinotecan fluorouracil and leucovorin calcium with or without hepatic chemoembolization
Compare response in the liver time to hepatic tumor progression and time to extrahepatic tumor progression in patients treated with these regimens
Compare the possible treatment differences with respect to morbidity toxic effects of chemoembolization toxic effects of chemotherapy and death from cancer-related complications in these patients
OUTLINE This is a phase I dose-escalation study followed by a phase III randomized multicenter study Phase I closed as of 101402
Phase I Patients in phase I are sequentially enrolled to 1 of 3 treatment regimens Phase I closed as of 101402
Regimen A Patients receive irinotecan IV over 60-90 minutes leucovorin calcium IV and fluorouracil IV over 10 minutes on days 1 8 15 and 22 Patients undergo hepatic embolization with embolic suspension only on day 36
Regimen B Patients receive chemotherapy as in regimen A Patients undergo hepatic chemoembolization with lower-dose cisplatin doxorubicin and mitomycin on day 36
Regimen C Patients receive chemotherapy as in regimen A Patients undergo hepatic chemoembolization with higher-dose cisplatin doxorubicin and mitomycin on day 36
After 1 week of rest patients in all regimens receive a second 4-week course of systemic chemotherapy
Cohorts of 3-10 patients are sequentially enrolled until the maximum tolerated dose MTD of chemotherapy and chemoembolization is determined The MTD is defined as the dose preceding that at which at least 4 of 10 patients experience dose-limiting toxicity
Phase III Patients are stratified according to liver volume involvement less than 25 vs 25-50 vs more than 50 to less than 75 and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive irinotecan IV over 60-90 minutes leucovorin calcium IV and fluorouracil IV over 10 minutes on days 1 8 15 and 22 Courses repeat every 6 weeks in the absence of disease progression
Arm II Patients receive chemotherapy as in arm I Patients undergo hepatic chemoembolization with cisplatin doxorubicin and mitomycin on day 36 Chemotherapy repeats every 6 weeks in the absence of disease progression Chemoembolization may repeat every 6 weeks for 2-4 courses as necessary
Patients in phase III are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 9-18 patients will be accrued for phase I of this study Phase I closed to accrual as of 101402 Approximately 315 patients will be accrued for phase III of this study within 25 years
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 |
|---|---|---|---|
| U01CA080098 | NIH | American College of Radiology Imaging Network | httpsreporternihgovquickSearchU01CA080098 |
| ACRIN-6655 | OTHER | None | None |
| U01CA079778 | NIH | None | None |