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

Pancreatic Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00642733
• Other study ID #: ML21285
• Status: Terminated
• Phase: Phase 4
• First received: March 19, 2008
• Last updated: August 22, 2016
• Start date: August 2007
• Est. completion date: April 2009

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Comision Federal para la Proteccion Contra Riesgos Santarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• erlotinib [Tarceva]
100mg po daily
• gemcitabine
1000mg/m2 iv weekly for 8 weeks, then weekly for 3 weeks of each 4 week cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival; time to progression		6 months	No
Secondary	Duration of response; disease-free survival		Event driven	No
Secondary	AEs, lab parameters		Throughout study	No