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

Roche

Status and phase: Terminated; Phase 4

Conditions: Pancreatic Cancer

Treatments: Drug: erlotinib [Tarceva]; Drug: gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00642733

ML21285

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

1

Experimental group

Treatment:

Drug: gemcitabine

Drug: erlotinib [Tarceva]