Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030524
Status:
COMPLETED
Last Update Posted:
2012-10-30
First Post:
2002-02-14
Brief Title:
ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
A Phase II Clinical Biological and Pharmacological Study of ZD1839 in Patients With Advanced Colorectal Carcinoma Refractory to 5-Fluorouracil 5-FU and Irinotecan Chemotherapy
Status:
COMPLETED
Status Verified Date:
2012-10
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 Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of colorectal cancer
PURPOSE Phase II trial to study the effectiveness of ZD 1839 in treating patients who have locally advanced or metastatic colorectal cancer that has not responded to chemotherapy
PURPOSE Phase II trial to study the effectiveness of ZD 1839 in treating patients who have locally advanced or metastatic colorectal cancer that has not responded to chemotherapy
Detailed Description:
OBJECTIVES
Determine the progression-free rate at 16 weeks response rate time to treatment failure and survival of patients treated with gefitinib for locally advanced or metastatic colorectal adenocarcinoma that is refractory to fluorouracil irinotecan and capecitabine
Correlate the pharmacodynamic effects of this drug with indices of clinical benefit eg tumor growth inhibition time to tumor progression and survival in these patients
Determine whether the status of epidermal growth factor receptor activation and signaling are predictive of clinical outcome in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral gefitinib once daily Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 18-46 patients will be accrued for this study within 5-12 months
Determine the progression-free rate at 16 weeks response rate time to treatment failure and survival of patients treated with gefitinib for locally advanced or metastatic colorectal adenocarcinoma that is refractory to fluorouracil irinotecan and capecitabine
Correlate the pharmacodynamic effects of this drug with indices of clinical benefit eg tumor growth inhibition time to tumor progression and survival in these patients
Determine whether the status of epidermal growth factor receptor activation and signaling are predictive of clinical outcome in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral gefitinib once daily Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 18-46 patients will be accrued for this study within 5-12 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 |
|---|---|---|---|
| NCI-3753 | None | None | None |
| UTHSC-0015011185 | None | None | None |
| SACI-IDD-01-01 | None | None | None |