Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006015
Status:
TERMINATED
Last Update Posted:
2013-05-03
First Post:
2000-07-05
Brief Title:
Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced Recurrent or Metastatic Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study Evaluating the Combination of 5-Fluorouracil Leucovorin Oxaliplatin and Herceptin in the Treatment of Patients With Metastatic Colorectal Cancer Who Have Progressed After 5-FU andor Irinotecan-Containing Therapy
Status:
TERMINATED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of sufficient accrual
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 trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE This phase II trial is studying combination chemotherapy plus trastuzumab to see how well it works in treating patients with advanced recurrent or metastatic colorectal cancer
PURPOSE This phase II trial is studying combination chemotherapy plus trastuzumab to see how well it works in treating patients with advanced recurrent or metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Determine the response rate of patients who overexpress HER-2neu with metastatic colorectal adenocarcinoma who have progressed on at least 1 prior but no more than 2 prior chemotherapy regimens for metastatic colorectal cancer treated with fluorouracil leucovorin calcium oxaliplatin and trastuzumab Herceptin
Determine the time to progression of these patients treated with this regimen
Determine the overall toxicity of this regimen in these patients
OUTLINE Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 15 and 22 followed by oxaliplatin IV over 2 hours on days 1 and 15 and then followed by leucovorin calcium IV over 2 hours on days 1 8 and 15 Fluorouracil IV is administered at the midpoint of the leucovorin calcium infusion on days 1 8 and 15 Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression
PROJECTED ACCRUAL A total of 20-45 patients will be accrued for this study
Determine the response rate of patients who overexpress HER-2neu with metastatic colorectal adenocarcinoma who have progressed on at least 1 prior but no more than 2 prior chemotherapy regimens for metastatic colorectal cancer treated with fluorouracil leucovorin calcium oxaliplatin and trastuzumab Herceptin
Determine the time to progression of these patients treated with this regimen
Determine the overall toxicity of this regimen in these patients
OUTLINE Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 15 and 22 followed by oxaliplatin IV over 2 hours on days 1 and 15 and then followed by leucovorin calcium IV over 2 hours on days 1 8 and 15 Fluorouracil IV is administered at the midpoint of the leucovorin calcium infusion on days 1 8 and 15 Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression
PROJECTED ACCRUAL A total of 20-45 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 |
|---|---|---|---|
| CALGB-89902 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |