Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336700
Status:
TERMINATED
Last Update Posted:
2016-09-19
First Post:
2006-06-12
Brief Title:
A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
Sponsor:
Herbert J Zeh III MD FACS
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study published November 2010 and no further work will be done
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study Hypothesis To estimate time to recurrence in pancreatic cancer patients treated with adjuvant erlotinib and gemcitabine Combination therapy will be given for 4 months followed by single agent erlotinib for a total of 12 months
Detailed Description:
PATIENT POPULATION Resected pancreatic cancer patients R0 resection within 10 weeks of surgery will be eligible provided that they meet standard eligibility criteria
STUDY DESIGN Phase II open-label trial of erlotinib and gemcitabine SAFETY PLAN Safety as assessed by CTCAE 30 STUDY TREATMENT Erlotinib 150 mgday x 12 months oral Gemcitabine 1500 mgm2 IV over 150 minutes q 2 weeks x 4 months Patients will be monitored with serial CT scans for the first 2 years after completion of therapy
Clinical Practice Therapy will be administered as an outpatient Primary Evaluations Time to recurrence CONCOMITANT THERAPY AND CLINICAL PRACTICE No other anti-cancer therapy will be allowed while on study
STUDY DESIGN Phase II open-label trial of erlotinib and gemcitabine SAFETY PLAN Safety as assessed by CTCAE 30 STUDY TREATMENT Erlotinib 150 mgday x 12 months oral Gemcitabine 1500 mgm2 IV over 150 minutes q 2 weeks x 4 months Patients will be monitored with serial CT scans for the first 2 years after completion of therapy
Clinical Practice Therapy will be administered as an outpatient Primary Evaluations Time to recurrence CONCOMITANT THERAPY AND CLINICAL PRACTICE No other anti-cancer therapy will be allowed while on 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