Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063947
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2003-07-08
Brief Title:
Erlotinib Gemcitabine and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of OSI-774 in Combination With Gemcitabine and Radiation in Locally Advanced Non-Operable Pancreatic 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 I trial is studying the side effects and best dose of erlotinib when given together with gemcitabine and radiation therapy in treating patients with locally advanced unresectable pancreatic cancer Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Drugs used in chemotherapy such as gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining erlotinib with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of erlotinib given concurrently with gemcitabine and radiotherapy in patients with locally advanced unresectable pancreatic cancer
SECONDARY OBJECTIVES
I Determine the toxicity of this regimen in these patients II Determine preliminarily the antitumor efficacy of this regimen in terms of response rate in these patients
III Determine the time to tumor progression and overall survival of patients treated with this regimen
OUTLINE This is a non-randomized open-label dose-escalation study of erlotinib
Chemoradiotherapy Patients undergo radiotherapy 5 days a week for 55 weeks Beginning on day 1 and continuing concurrently with radiotherapy patients receive gemcitabine IV over 30 minutes twice weekly and oral erlotinib once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional 10 patients receive treatment at that dose
Patients are radiologically restaged 3-4 weeks after completion of radiotherapy Patients with stable or responsive disease proceed to maintenance therapy Patients whose imaging studies suggest a potential for curative resection are referred for a surgical evaluation before initiating maintenance therapy
Maintenance therapy Beginning 4-7 weeks after the completion of chemoradiotherapy patients receive maintenance chemotherapy comprising gemcitabine IV over 30 minutes on days 1 and 8 and oral erlotinib once daily Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 19-28 patients will be accrued for this study
I Determine the maximum tolerated dose of erlotinib given concurrently with gemcitabine and radiotherapy in patients with locally advanced unresectable pancreatic cancer
SECONDARY OBJECTIVES
I Determine the toxicity of this regimen in these patients II Determine preliminarily the antitumor efficacy of this regimen in terms of response rate in these patients
III Determine the time to tumor progression and overall survival of patients treated with this regimen
OUTLINE This is a non-randomized open-label dose-escalation study of erlotinib
Chemoradiotherapy Patients undergo radiotherapy 5 days a week for 55 weeks Beginning on day 1 and continuing concurrently with radiotherapy patients receive gemcitabine IV over 30 minutes twice weekly and oral erlotinib once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional 10 patients receive treatment at that dose
Patients are radiologically restaged 3-4 weeks after completion of radiotherapy Patients with stable or responsive disease proceed to maintenance therapy Patients whose imaging studies suggest a potential for curative resection are referred for a surgical evaluation before initiating maintenance therapy
Maintenance therapy Beginning 4-7 weeks after the completion of chemoradiotherapy patients receive maintenance chemotherapy comprising gemcitabine IV over 30 minutes on days 1 and 8 and oral erlotinib once daily Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 19-28 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 |
|---|---|---|---|
| U01CA069856 | NIH | None | httpsreporternihgovquickSearchU01CA069856 |
| 03-031 | None | None | None |
| NCI-5441 | None | None | None |
| CDR0000305855 | None | None | None |
| MSKCC-03031 | None | None | None |