Back to resultsA Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Terminated
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
erlotinib [Tarceva]
gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- pancreatic cancer, surgically unresectable or with metastases;
- no previous chemotherapy (except concomitant with radiotherapy);
- ECOG 0-2.
Exclusion Criteria:
- pancreatic cancer without histologic or cytologic confirmation;
- surgical resection possible;
- previous chemotherapy not concomitant with radiotherapy;
- ECOG 3-4.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Overall survival; time to progression
Secondary Outcome Measures
Duration of response; disease-free survival
AEs, lab parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00642733
Brief Title
A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Official Title
An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Overall Survival and Disease Progression in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This single arm study will assess the efficacy and safety of Tarceva + gemcitabine in patients with locally advanced, unresectable or metastatic pancreatic cancer. Patients will receive Tarceva 100mg po daily, in combination with gemcitabine 1000mg/m2 iv weekly for 8 weeks, followed by weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
erlotinib [Tarceva]
Intervention Description
100mg po daily
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
1000mg/m2 iv weekly for 8 weeks, then weekly for 3 weeks of each 4 week cycle
Primary Outcome Measure Information:
Title
Overall survival; time to progression
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Duration of response; disease-free survival
Time Frame
Event driven
Title
AEs, lab parameters
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
pancreatic cancer, surgically unresectable or with metastases;
no previous chemotherapy (except concomitant with radiotherapy);
ECOG 0-2.
Exclusion Criteria:
pancreatic cancer without histologic or cytologic confirmation;
surgical resection possible;
previous chemotherapy not concomitant with radiotherapy;
ECOG 3-4.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Morelia
ZIP/Postal Code
58070
Country
Mexico
City
Tijuana
ZIP/Postal Code
22320
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
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