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

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

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.
Study Started
Mar 31
Primary Completion
Aug 31
Study Completion
Aug 31
Last Update
Aug 18

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

  • Other names: capecitabine (Xeloda®)y erlotinib (Tarceva®)

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


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
No Results Posted