Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482222
Status:
UNKNOWN
Last Update Posted:
2013-01-23
First Post:
2007-06-04
Brief Title:
Combination Chemotherapy With or Without Cetuximab Before and After Surgery in Treating Patients With Resectable Liver Metastases Caused By Colorectal Cancer
Sponsor:
University of Southampton
Organization:
University of Southampton
Study Overview
Official Title:
A Prospective Randomised Open Label Trial of OxaliplatinFluoropyrimidine Versus OxaliplatinFluoropyrimidine Plus Cetuximab Pre and Post Operatively in Patients With Resectable Colorectal Liver Metastasis Requiring Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2008-04
Last Known Status:
RECRUITING
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 oxaliplatin fluorouracil leucovorin and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as cetuximab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving these treatments after surgery may kill any tumor cells that remain after surgery It is not yet known whether combination chemotherapy is more effective with or without cetuximab in treating liver metastases caused by colorectal cancer
PURPOSE This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without cetuximab before and after surgery in treating patients with resectable liver metastases caused by colorectal cancer
PURPOSE This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without cetuximab before and after surgery in treating patients with resectable liver metastases caused by colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Compare progression-free survival of patients with resectable colorectal liver metastases treated with neoadjuvant and adjuvant combination chemotherapy with vs without cetuximab
Secondary
Compare the overall survival of patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the cost effectiveness of these regimens in these patients
OUTLINE This is a prospective randomized multicenter open-label study Patients are stratified according to participating center and assigned chemotherapy regimen Patients are randomized to 1 of 2 treatment arms
Neoadjuvant therapy
Arm I Patients receive 1 of the following chemotherapy regimens
OxMdG Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1 Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
CAPOX Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive 1 of the following regimens
OxMdG cetuximab Patients receive cetuximab IV over 1-2 hours on day 1 and OxMdG chemotherapy as in arm I Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
CAPOX cetuximab Patients receive cetuximab IV over 1-2 hours on days 1 8 and 15 and CAPOX chemotherapy as in arm I Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Surgery Beginning 2-6 weeks after completion of chemotherapy patients in both arms undergo liver resection
Adjuvant therapy Beginning 4-8 weeks after completion of surgery patients receive treatment OxMdG or CAPOX with or without cetuximab as in arm I or II of neoadjuvant therapy
Arm I Treatment with OxMdG repeats every 2 weeks for up to 6 courses and treatment with CAPOX repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Treatment with OxMdG cetuximab repeats every 2 weeks for up to 6 courses and treatment with CAPOX cetuximab repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 12 weeks during chemotherapy at completion of study treatment every 3 months for 1 year and then every 6 months thereafter
Cost per life year and per quality-adjusted life year is assessed at baseline every 12 weeks during treatment and then at 3 5 and 10 years
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Primary
Compare progression-free survival of patients with resectable colorectal liver metastases treated with neoadjuvant and adjuvant combination chemotherapy with vs without cetuximab
Secondary
Compare the overall survival of patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the cost effectiveness of these regimens in these patients
OUTLINE This is a prospective randomized multicenter open-label study Patients are stratified according to participating center and assigned chemotherapy regimen Patients are randomized to 1 of 2 treatment arms
Neoadjuvant therapy
Arm I Patients receive 1 of the following chemotherapy regimens
OxMdG Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1 Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
CAPOX Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive 1 of the following regimens
OxMdG cetuximab Patients receive cetuximab IV over 1-2 hours on day 1 and OxMdG chemotherapy as in arm I Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
CAPOX cetuximab Patients receive cetuximab IV over 1-2 hours on days 1 8 and 15 and CAPOX chemotherapy as in arm I Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Surgery Beginning 2-6 weeks after completion of chemotherapy patients in both arms undergo liver resection
Adjuvant therapy Beginning 4-8 weeks after completion of surgery patients receive treatment OxMdG or CAPOX with or without cetuximab as in arm I or II of neoadjuvant therapy
Arm I Treatment with OxMdG repeats every 2 weeks for up to 6 courses and treatment with CAPOX repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Treatment with OxMdG cetuximab repeats every 2 weeks for up to 6 courses and treatment with CAPOX cetuximab repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 12 weeks during chemotherapy at completion of study treatment every 3 months for 1 year and then every 6 months thereafter
Cost per life year and per quality-adjusted life year is assessed at baseline every 12 weeks during treatment and then at 3 5 and 10 years
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
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 |
|---|---|---|---|
| EU-20732 | None | None | None |
| USCTU-4351 | None | None | None |
| USCTU-EPOC | None | None | None |
| EUDRACT-2006-003121-82 | None | None | None |
| ISRCTN22944367 | None | None | None |