Trial To Evaluate The Efficacy And Safety Of Tarceva And Capecitabine In Advanced Pancreatic Cancer Patients

Study Overview

Trial to Evaluate the Efficacy and Safety of Tarceva and Capecitabine in Advanced Pancreatic Cancer Patients

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

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

Metastatic Adenocarcinoma of the Pancreas

DRUG: capecitabine + erlotinib

ML21154
2007-003206-96 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-03-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2010-08-17
First Submitted that Met QC Criteria 2009-03-31	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2010-08-18
First Posted (ESTIMATED) 2009-04-01	Results First Posted N/A	Last Verified 2010-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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	DRUG: capecitabine + erlotinib 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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

DRUG: capecitabine + erlotinib

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

Primary Outcome Measures	Measure Description	Time Frame
Objective response rate following RECIST criteria		within study period

Secondary Outcome Measures	Measure Description	Time Frame
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Absolute Neutrophil account (ANC) ≥ 1,5 x 109/L
Platelets: ≥ 100 x 109/L
Hemoglobin: ≥ 9 g/dL. 10. Adequate liver function, as determined by:

Serum bilirubin (total): ≤ 1,5 x LSN
AST, ALT ≤ 2,5 x LSN in patients without liver metastasis. In patients with liver metastasis ≤ 5 x LSN 11. Adequate renal function, as determined by:

Clearance creatinine > 60.0 ml/min 12. Men or women potentially fertile (including postmenopausal women amenorrheic at least 24 months before the study) should use adequate contraceptive methods (oral contraceptives, intrauterine disposal, barrier methods together with spermicide or surgery sterilization)

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 6. Significant ophthalmology anomalies 7. Deficit in dihydropyrimidine dehydrogenase (DPD) 8. Unable to take oral drug. Previous surgical process that affect the absorption or make the needed to have intravenous feeding or parenteral nutrition with lipids. 9. Pregnancy women or in latency period. Negative pregnancy test needed 7 days prior to initiation drug study 10. Actual or 30 days previous to study treatment with other investigational drug or participation in other trial 11. Previous treatment with Capecitabine or EGFR inhibitor. 12. Any other disease, metabolic disease 13. Known hypersensibility to any study drug or any of their component, or to 5-fluorouracile

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Rafel López López, Coordinator, Grupo Gallego de Investigaciones Oncológicas

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record