Trial information
A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Status: Terminated
Protocol number: ML21285
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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
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. Target sample size is
30.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Pancreatic Cancer
Intervention type: Drug
Intervention name: erlotinib [Tarceva]
Primary outcome: 1. Overall survival; time to progression Time frame: 6 months
Key secondary outcomes: 1. Duration of response; disease-free survival Time frame: Event driven
2. AEs, lab parameters Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 03/18/2008
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Mexico
