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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

Phase 2
18 Years
Not Enrolling
Metastatic Adenocarcinoma of the Pancreas

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Trial Information

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

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

Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent

2. Informed consent signed by the patient

3. Age > 18 years old

4. Able to fulfill all criteria from the protocol

5. Performance status Karnofsky ≥ 60% (ECOG 0-2)

6. Life expectancy ≥ 12 weeks

7. Histologically or cytological (excluding endocrine pancreatic tumour), with
metastatic (stage IV), following 6th edition of TNM classification

8. Measurable disease following RECIST criteria

9. 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.

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)

Exclusion Criteria:

1. 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.

2. 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.

3. 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

4. Primary tumours Developer 5 years previous to the inclusion, except in situ cérvix
carcinoma or skin basocellular cancer properly treated

5. Non-controlled hypertension or cardiovascular disease clinically significant

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate following RECIST criteria

Outcome Time Frame:

within study period

Safety Issue:


Principal Investigator

Rafel López López, Coordinator

Investigator Role:

Study Chair

Investigator Affiliation:

Grupo Gallego de Investigaciones Oncológicas


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

March 2008

Completion Date:

August 2010

Related Keywords:

  • Metastatic Adenocarcinoma of the Pancreas
  • Metastatic Adenocarcinoma of the Pancreas
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms