A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Phase 4TerminatedNCT00642733

Hoffmann-La Roche6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

erlotinib [Tarceva]DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Unnamed facility

Morelia, Mexico

Unnamed facility

Tijuana, Mexico

Outcomes

Primary Outcomes

Overall survival; time to progression

Time frame: 6 months

Secondary Outcomes

Duration of response; disease-free survival

Time frame: Event driven

AEs, lab parameters

Time frame: Throughout study