Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045526
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2002-09-06
Brief Title:
Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study Of OSI-774 In Advanced Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This phase II trial is studying erlotinib hydrochloride to see how well it works in treating patients with advanced esophageal cancer or stomach cancer Erlotinib hydrochloride may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the objective response rate in patients with advanced carcinoma of the esophagus or gastroesophageal junction treated with erlotinib erlotinib hydrochloride
II Determine the overall survival of patients treated with this drug III Determine the degree of dysphagia relief in patients treated with this drug
IV Determine the toxicity and tolerability of this drug in these patients V Correlate epidermal growth factor receptor EGFR expression with response to treatment in these patients
OUTLINE
Patients receive erlotinib hydrochloride orally PO once daily QD Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
I Determine the objective response rate in patients with advanced carcinoma of the esophagus or gastroesophageal junction treated with erlotinib erlotinib hydrochloride
II Determine the overall survival of patients treated with this drug III Determine the degree of dysphagia relief in patients treated with this drug
IV Determine the toxicity and tolerability of this drug in these patients V Correlate epidermal growth factor receptor EGFR expression with response to treatment in these patients
OUTLINE
Patients receive erlotinib hydrochloride orally PO once daily QD Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| N01CM62206 | NIH | None | httpsreporternihgovquickSearchN01CM62206 |
| 02-035 | None | None | None |
| NSC-718781 | None | None | None |
| NCI-5445 | None | None | None |
| CDR0000256601 | None | None | None |
| MSKCC-02035 | None | None | None |