Canadian Cancer Trials Group - Tumour Bank
Logged in as: Public
Location: Home - Disease Sites - - PA3
PA3 Details
Status: Closed 
Activation Date: 2001OCT29
Closing Date: 2003JAN31
Phase: III 

Description: A Randomized Placebo Controlled Study of OSI-774 Plus Gemcitabine in Patients with Locally Advanced, Unresectable or Metastatic Pancreatic Cancer 

Eligibility: Patients with locally advanced, unresectable or metastatic adenocarcinoma of the pancreas who have received no prior chemotherapy other than 5FU (plus/ minus folinic acid) or gemcitabine given concurrently with radiation treatment as a radiosensitiser. Patients must have evidence of disease, but measureable disease is not mandatory. 

Objective: The primary objective of the study is to compare the survival of patients in the two treatment groups, gemcitabine plus OSI-774 and gemcitabine plus placebo. Secondary objectives include comparison between the two groups of progression-free survival; quality of life; response rate; response duration; and toxicities. Further secondary objectives are to correlate the expression of tissue EGFR levels (at diagnosis) with outcomes and response to treatment, and to measure trough levels of OSI-774 to define population pharmacokinetics. 

Participation: Initially limited to Canadian centres with IND Program experience; opened world-wide Mar 30, 2002. 

Primary Publication Show

Other Publications Show

Inventory
Hide Tissue Samples
Disease Site Trial Code Patients Accrued Patients - Blocks Patients - Slides Patients - Blocks and/or Slides
GASTRO-INTESTINAL PA3 569 172 252 284
Hide TMA Samples
(Core size is 0.6 mm)
Disease Site Trial Code Patients Accrued TMA Blocks Patients on TMA Blocks
GASTRO-INTESTINAL PA3 569 0 0
Hide Fluid Samples
Disease Site Trial Code Patients Accrued Patients - Whole Blood Patients - Cellular Component of Blood Patients - DNA extracted from Blood Patients - RNA extracted from Blood Patients - Plasma Patients - Serum Patients - Urine Patients - Buccal
GASTRO-INTESTINAL PA3 569 0 0 0 0 509 0 0 0