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

NCT00873353 | Completed Phase 2

• 2 other identifiers: ML211542007-003206-96
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 8

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.

Conditions

Metastatic Adenocarcinoma of the Pancreas

Keywords

Metastatic Adenocarcinoma of the Pancreas

Outcome Measures

Primary Outcomes (1)

• Objective response rate following RECIST criteria

  within study period

Secondary Outcomes (6)

• 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

Study Arms (1)

Unique arm

EXPERIMENTAL

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

Interventions

capecitabine + erlotinib DRUG

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

Also known as: capecitabine (Xeloda®)y erlotinib (Tarceva®)

Unique arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Platelets: ≥ 100 x 109/L
• Hemoglobin: ≥ 9 g/dL.
• 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

You may not qualify if:

• 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.
• Non-controlled hypertension or cardiovascular disease clinically significant (active):
• Instable angina
• Congestive cardiac insufficiency (grade II or superior following to New York Heart Association (NYHA)
• Severe cardiac arrhythmia that require medication
• Significant ophthalmology anomalies
• Deficit in dihydropyrimidine dehydrogenase (DPD)
• 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.
• Pregnancy women or in latency period. Negative pregnancy test needed 7 days prior to initiation drug study
• Actual or 30 days previous to study treatment with other investigational drug or participation in other trial
• Previous treatment with Capecitabine or EGFR inhibitor.
• Any other disease, metabolic disease
• Known hypersensibility to any study drug or any of their component, or to 5-fluorouracile

Sponsors & Collaborators

• Grupo Gallego de Investigaciones Oncologicas: lead

Study Sites (8)

Complejo Hospitalario Universitario de La Coruña

A Coruña, La Coruña, 15006, Spain

Location

Centro Oncológico de Galicia

A Coruña, La Coruña, 15009, Spain

Location

Hospital Arquitecto Marcide

Ferrol, La Coruña, 15405, Spain

Location

Complejo Hospitalario Xeral Calde

Lugo, Lugo, 27004, Spain

Location

Complejo Hospitalario de Orense

Ourense, Orense, 32005, Spain

Location

Hospital do Meixoeiro

Vigo, Vigo, 36200, Spain

Location

Complejo Hospitalario Xeral Cies

Vigo, Vigo, 36204, Spain

Location

Hospital POVISA

Vigo, Vigo, 36211, Spain

Location

MeSH Terms

Interventions

Capecitabine; Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Rafel López López, Coordinator

  Grupo Gallego de Investigaciones Oncológicas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 1, 2009
• Study Start: March 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2010
• Last Updated: August 18, 2010

Record last verified: 2010-08

Locations

ES (8)