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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00642733

Enrollment

Registered

2008-03-25

Start date

2007-08-31

Completion date

2009-04-30

Last updated

2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Brief summary

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.

Interventions

DRUGerlotinib [Tarceva]

100mg po daily

DRUGgemcitabine

1000mg/m2 iv weekly for 8 weeks, then weekly for 3 weeks of each 4 week cycle

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Overall survival; time to progression	6 months

Secondary

Measure	Time frame
Duration of response; disease-free survival	Event driven
AEs, lab parameters	Throughout study

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026