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

This study has been completed.
Sponsor:
Information provided by:
Grupo Gallego de Investigaciones Oncologicas
ClinicalTrials.gov Identifier:
NCT00873353
First received: March 31, 2009
Last updated: August 17, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Metastatic Adenocarcinoma of the Pancreas
Drug: capecitabine + erlotinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Grupo Gallego de Investigaciones Oncologicas:

Primary Outcome Measures:
  • Objective response rate following RECIST criteria [ Time Frame: within study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: within study period ] [ Designated as safety issue: No ]
  • 6 months survival rate [ Time Frame: within first 6 months after study inclusion ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: Time from study inclusion to disease progression ] [ Designated as safety issue: No ]
  • Time to treatment failure (TTF) [ Time Frame: Time from study inclusion to treatment failure ] [ Designated as safety issue: No ]
  • To determine the index of clinical benefit [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • To determine the safety and tolerability of erlotinib and capecitabine when administered together [ Time Frame: Within study period ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: March 2008
Study Completion Date: August 2010
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873353

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

No publications provided

Responsible Party: Rafael López López, Grupo Gallego de Investigaciones Oncologicas
ClinicalTrials.gov Identifier: NCT00873353     History of Changes
Other Study ID Numbers: ML21154, 2007-003206-96
Study First Received: March 31, 2009
Last Updated: August 17, 2010
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Capecitabine
Erlotinib
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014