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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival; time to progression

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Mexico: Comision Federal para la Proteccion Contra Riesgos Santarios

Study ID:

ML21285

NCT ID:

NCT00642733

Start Date:

Completion Date:

May 2010

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

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