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

Study Overview
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Brief Summary
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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
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This efficacy will be determined by objective response rate following RECIST criteria.

Official Title
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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

Conditions
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Metastatic Adenocarcinoma of the Pancreas

Intervention / Treatment
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* Drug: capecitabine + erlotinib


Participation Criteria
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Eligibility Criteria
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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 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 Adequate renal function, as determined by: Clearance creatinine > 60.0 ml/min 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) 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unique arm<br>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<br>* 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<br>* Other names: capecitabine (Xeloda®)y erlotinib (Tarceva®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate following RECIST criteria |  | within study period | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Adenocarcinoma of the Pancreas