Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032110
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2002-03-08
Brief Title:
Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of OSI-774 in Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or metastatic colorectal cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the efficacy of erlotinib in terms of response rate and duration of stable disease in patients with recurrent or metastatic colorectal cancer
II Determine the toxicity of this drug in these patients III Determine the time to progression and response duration in patients treated with this drug
IV Determine the relationships between clinical pharmacokinetic and pharmacodynamic effects of this drug in these patients
V Correlate baseline and post-treatment levels of epidermal growth factor receptor its downstream signaling components markers of angiogenesis and apoptosis in tumor and skin biopsies with clinical outcome in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral erlotinib once daily Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 2 additional courses after CR is confirmed
Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 4-8 months
I Determine the efficacy of erlotinib in terms of response rate and duration of stable disease in patients with recurrent or metastatic colorectal cancer
II Determine the toxicity of this drug in these patients III Determine the time to progression and response duration in patients treated with this drug
IV Determine the relationships between clinical pharmacokinetic and pharmacodynamic effects of this drug in these patients
V Correlate baseline and post-treatment levels of epidermal growth factor receptor its downstream signaling components markers of angiogenesis and apoptosis in tumor and skin biopsies with clinical outcome in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral erlotinib once daily Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 2 additional courses after CR is confirmed
Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 4-8 months
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 |
|---|---|---|---|
| N01CM17107 | NIH | CTEP | httpsreporternihgovquickSearchN01CM17107 |
| NCI-2012-02459 | REGISTRY | None | None |
| CDR0000069258 | None | None | None |
| PHL-003 | None | None | None |
| NCI-5378 | None | None | None |
| PHL-003 | OTHER | None | None |
| 5378 | OTHER | None | None |