Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033241
Status:
COMPLETED
Last Update Posted:
2018-01-10
First Post:
2002-04-09
Brief Title:
Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors
Sponsor:
OSI Pharmaceuticals
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase Ib Multicenter Trial To Determine The Safety Tolerance And Preliminary Antineoplastic Activity Of Gemcitabine Administered In Combination With Escalating Oral Doses Of OSI-774 To Patient Cohorts With Recently Diagnosed Gemcitabine-Naive Advanced Pancreatic Carcinoma Or Other Potentially Responsive Malignancies
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining erlotinib with gemcitabine may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining erlotinib with gemcitabine in treating patients who have newly diagnosed locally advanced or metastatic pancreatic cancer or other solid tumors
PURPOSE Phase I trial to study the effectiveness of combining erlotinib with gemcitabine in treating patients who have newly diagnosed locally advanced or metastatic pancreatic cancer or other solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of erlotinib in combination with gemcitabine in patients with recently diagnosed gemcitabine-naive locally advanced or metastatic pancreatic carcinoma or other potentially responsive solid tumor
Determine the safety and tolerability of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine the objective antitumor response rate and response duration in patients treated with this regimen
Determine the time to disease progression and duration of overall survival in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of erlotinib
Patients receive gemcitabine IV over 30 minutes on day 1 of weeks 1-7 and oral erlotinib once daily beginning on day 3 of week 1 and continuing for 8 weeks course 1 Patients receive subsequent courses of therapy comprising gemcitabine once weekly for 3 weeks and erlotinib once daily Courses repeat every 4 weeks 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 12 additional patients are accrued and treated at the MTD as above
Patients are followed at 30 days
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study within 3 months
Determine the maximum tolerated dose of erlotinib in combination with gemcitabine in patients with recently diagnosed gemcitabine-naive locally advanced or metastatic pancreatic carcinoma or other potentially responsive solid tumor
Determine the safety and tolerability of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine the objective antitumor response rate and response duration in patients treated with this regimen
Determine the time to disease progression and duration of overall survival in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of erlotinib
Patients receive gemcitabine IV over 30 minutes on day 1 of weeks 1-7 and oral erlotinib once daily beginning on day 3 of week 1 and continuing for 8 weeks course 1 Patients receive subsequent courses of therapy comprising gemcitabine once weekly for 3 weeks and erlotinib once daily Courses repeat every 4 weeks 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 12 additional patients are accrued and treated at the MTD as above
Patients are followed at 30 days
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study within 3 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-V02-1694 | None | None | None |
| CDR0000069266 | None | None | None |
| UARIZ-HSC-01128 | None | None | None |