A Randomized, Open-label, Dose-escalation to Rash Study to Assess the Effect of Tarceva in Combination With Gemcitabine on Overall Survival in Patients With Metastatic Pancreatic Cancer.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer
Both
Pancreatic Cancer
Trial Information
A Randomized, Open-label, Dose-escalation to Rash Study to Assess the Effect of Tarceva in Combination With Gemcitabine on Overall Survival in Patients With Metastatic Pancreatic Cancer.
Inclusion Criteria:
- adult patients, >=18 years of age;
- histologically or cytologically confirmed pancreatic cancer with measurable or
non-measurable metastatic disease;
- ECOG performance status of 0-1.
Exclusion Criteria:
- local, or locally advanced, pancreatic cancer;
- prior systemic treatment for metastatic pancreatic cancer;
- <=6 months since last adjuvant chemotherapy;
- other malignancies within last 5 years, except for adequately treated cancer in situ
of the cervix, or basal or squamous cell skin cancer.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Italy:National Institue of Health
Study ID:
BO21128
NCT ID:
NCT00652366
Start Date:
May 2008
Completion Date:
April 2012
Related Keywords:
- Pancreatic Cancer
- Pancreatic Neoplasms
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