An Open Non-randomized Multicenter Phase II Trial to Evaluate the Efficacy and Safety of Tarceva in Combination With Capecitabine in Patients With Advanced Pancreatic Cancer

Grupo Gallego de Investigaciones Oncologicas8 sites in 1 country32 target enrollmentMarch 2008

ConditionsMetastatic Adenocarcinoma of the Pancreas

Interventionscapecitabine + erlotinib

Drugscapecitabine + erlotinib

Overview

Phase: Phase 2
Intervention: capecitabine + erlotinib
Conditions: Metastatic Adenocarcinoma of the Pancreas
Sponsor: Grupo Gallego de Investigaciones Oncologicas
Enrollment: 32
Locations: 8
Primary Endpoint: Objective response rate following RECIST criteria
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine efficacy of the treatment with erlotinib in combination with capecitabine in patients with advanced pancreatic cancer.

Detailed Description

This efficacy will be determined by objective response rate following RECIST criteria.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

August 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Grupo Gallego de Investigaciones Oncologicas

Eligibility Criteria

Inclusion Criteria

•Ability to understand and willingness to sign a written informed consent
•Informed consent signed by the patient
•Age \> 18 years old
•Able to fulfill all criteria from the protocol
•Performance status Karnofsky ≥ 60% (ECOG 0-2)
•Life expectancy ≥ 12 weeks
•Histologically or cytological (excluding endocrine pancreatic tumour), with metastatic (stage IV), following 6th edition of TNM classification
•Measurable disease following RECIST criteria
•Adequate bone marrow function as determined by:
•Absolute Neutrophil account (ANC) ≥ 1,5 x 109/L

Exclusion Criteria

•Local pancreatic cancer (stage IA-IIB) or locally advance cancer (stage III), following the TNM 6th edition classification. Patients with metastatic disease that relapse after the initial diagnosis of local or advance disease could be included in this study.
•Evidence of medullary compression, carcinomatosis meningitis or brain metastasis. In case of clinical suspicious of brain metastasis is mandatory to perform a brain TAC/MR 4 weeks prior inclusion.
•Previous systemic treatment for metastasis pancreas cancer. Adjuvant chemotherapy is permitted ≥ 4 weeks prior de inclusion. All toxicities from the adjuvant treatment must been solve before the inclusion and should be confirmed the diseases progression (metastatic disease) alter adjuvant treatment
•Primary tumours Developer 5 years previous to the inclusion, except in situ cérvix carcinoma or skin basocellular cancer properly treated
•Non-controlled hypertension or cardiovascular disease clinically significant (active):
•Cerebrovascular accident/ictus (≤ 6 weeks prior to inclusion)
•Heart attack (≤ 6 months prior to inclusion)
•Instable angina
•Congestive cardiac insufficiency (grade II or superior following to New York Heart Association (NYHA)
•Severe cardiac arrhythmia that require medication

Arms & Interventions

Unique arm

6 cycles (3 weeks each one) of : * capecitabine 1000mg/m2, bid, oral. Days: 1-14 every three weeks * erlotinib (Tarceva®) 150mg/day, oral. Days: every days

Intervention: capecitabine + erlotinib

Outcomes

Primary Outcomes

Objective response rate following RECIST criteria

Time Frame: within study period

Secondary Outcomes

Overall survival(within study period)
6 months survival rate(within first 6 months after study inclusion)
Progression Free Survival (PFS)(Time from study inclusion to disease progression)
Time to treatment failure (TTF)(Time from study inclusion to treatment failure)
To determine the index of clinical benefit(at the end of the study)
To determine the safety and tolerability of erlotinib and capecitabine when administered together(Within study period)