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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00873353
Recruitment Status : Completed
First Posted : April 1, 2009
Last Update Posted : August 18, 2010
Information provided by:
Grupo Gallego de Investigaciones Oncologicas

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.

Condition or disease Intervention/treatment Phase
Metastatic Adenocarcinoma of the Pancreas Drug: capecitabine + erlotinib Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
Other Name: capecitabine (Xeloda®)y erlotinib (Tarceva®)

Primary Outcome Measures :
  1. Objective response rate following RECIST criteria [ Time Frame: within study period ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: within study period ]
  2. 6 months survival rate [ Time Frame: within first 6 months after study inclusion ]
  3. Progression Free Survival (PFS) [ Time Frame: Time from study inclusion to disease progression ]
  4. Time to treatment failure (TTF) [ Time Frame: Time from study inclusion to treatment failure ]
  5. To determine the index of clinical benefit [ Time Frame: at the end of the study ]
  6. To determine the safety and tolerability of erlotinib and capecitabine when administered together [ Time Frame: Within study period ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 (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
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00873353

Hospital Arquitecto Marcide
Ferrol, La Coruña, Spain, 15405
Complejo Hospitalario Universitario de La Coruña
La Coruña, Spain, 15006
Centro Oncológico de Galicia
La Coruña, Spain, 15009
Complejo Hospitalario Xeral Calde
Lugo, Spain, 27004
Complejo Hospitalario de Orense
Orense, Spain, 32005
Hospital do Meixoeiro
Vigo, Spain, 36200
Complejo Hospitalario Xeral Cies
Vigo, Spain, 36204
Hospital POVISA
Vigo, Spain, 36211
Sponsors and Collaborators
Grupo Gallego de Investigaciones Oncologicas
Study Chair: Rafel López López, Coordinator Grupo Gallego de Investigaciones Oncológicas

Responsible Party: Rafael López López, Grupo Gallego de Investigaciones Oncologicas Identifier: NCT00873353     History of Changes
Other Study ID Numbers: ML21154
2007-003206-96 ( EudraCT Number )
First Posted: April 1, 2009    Key Record Dates
Last Update Posted: August 18, 2010
Last Verified: August 2010

Keywords provided by Grupo Gallego de Investigaciones Oncologicas:
Metastatic Adenocarcinoma of the Pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors