Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459901
Status:
TERMINATED
Last Update Posted:
2015-04-29
First Post:
2007-04-11
Brief Title:
Study of the Antitumor Activity of Capecitabine in Combination With Erlotinib in Patients With Metastatic Colorectal Cancer
Sponsor:
Peter Kozuch
Organization:
Beth Israel Medical Center
Study Overview
Official Title:
Phase II Trial of OSI-774 Erlotinib Tarceva and Capecitabine for Patients With Previously Untreated Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study halted by drug manufacturer
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer Time to tumor progression objective response rate time to confirmed response rate duration of confirmed response rate time to treatment failure and CEA response will be assessed
Detailed Description:
Approximately 150000 people are diagnosed with colorectal cancer in the United States each year Forty to fifty thousand people eventually will develop metastatic colorectal cancer and 40000 people die annually because of advanced or metastatic colorectal cancer Cancer patients prefer oral therapy over intravenous therapy as palliative treatment if efficacy regarding response rate and response duration is not compromised Therefore development of a completely oral combination therapy that approximates or improves upon the clinical outcomes attained by the reference triple drug therapies should be a research priority Compared with intravenous 5-fluourouracilleucovorin as first-line treatment for metastatic colorectal cancer oral capecitabine has demonstrated similar survival outcomes approximately 12-13 months response rates 15-20 and response durations 4-5 months in two multi-institutional international randomized phase III trials Erlotinib OSI-774 Tarceva is an orally available inhibitor of human EGFR tyrosine kinase The epidermal growth factor receptor EGFR is overexpressed in a variety of human cancers including colorectal cancer The principal goal of anticancer treatment with tyrosine kinase inhibitors such as erlotinib is to restore normal cellular growth by interrupting EGFR mediated cell proliferation and malignant The hypothesis of this phase II trial is that the unique mechanisms of action and non-overlapping toxicity profiles of capecitabine Xeloda and erlotinib will allow these drugs to be combined into a safe and tolerable regimen with better activity regarding response response duration and median survival than capecitabine alone in patients with previously untreated metastatic colorectal cancer
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 |
|---|---|---|---|
| XEL308 | None | None | None |