Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056030
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2003-03-06
Brief Title:
Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases From Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study Of Oxaliplatin OXAL 5-Fluorouracil 5-FU Leucovorin CF and Cetuximab C225 For Patients With Unresectable Hepatic Metastases From Metastatic Adenocarcinoma Of The Colon Or Rectum
Status:
COMPLETED
Status Verified Date:
2017-01
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 Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining chemotherapy with cetuximab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with cetuximab works in treating patients with unresectable liver metastases from colorectal cancer
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with cetuximab works in treating patients with unresectable liver metastases from colorectal cancer
Detailed Description:
OBJECTIVES
Determine the surgical resectability rate of patients with unresectable hepatic metastases secondary to metastatic colorectal adenocarcinoma treated with oxaliplatin fluorouracil leucovorin calcium and cetuximab
Determine the response rate and overall survival of patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive cetuximab IV over 1 hour over 2 hours on day 1 of course 1 only on days 1 and 8 Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-2 Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity for a minimum of 12 courses or until deemed to have resectable disease
Quality of life is assessed at baseline and prior to each treatment course
Patients are followed every 3 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 67-73 patients will be accrued for this study within 4 years
Determine the surgical resectability rate of patients with unresectable hepatic metastases secondary to metastatic colorectal adenocarcinoma treated with oxaliplatin fluorouracil leucovorin calcium and cetuximab
Determine the response rate and overall survival of patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive cetuximab IV over 1 hour over 2 hours on day 1 of course 1 only on days 1 and 8 Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-2 Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity for a minimum of 12 courses or until deemed to have resectable disease
Quality of life is assessed at baseline and prior to each treatment course
Patients are followed every 3 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 67-73 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| CDR0000271923 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02521 | REGISTRY | None | None |