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A Trial to Evaluate the Efficacy and Safety of Tarceva in Combination With Capecitabine in Patients With Advanced Pancreatic Cancer (XELTA)
This study is currently recruiting participants.
Verified by Grupo Gallego de Investigaciones Oncologicas, March 2009
First Received: March 31, 2009   No Changes Posted
Sponsored by: Grupo Gallego de Investigaciones Oncologicas
Information provided by: Grupo Gallego de Investigaciones Oncologicas
ClinicalTrials.gov Identifier: NCT00873353
  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 II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Capecitabine Erlotinib hydrochloride Erlotinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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 ]

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

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 medular 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)
    • Myocardial infart (≤ 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 absortion or make the needed to have intravenous feeding or parentheral 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873353

Locations
Spain, La Coruña
GGIO (Grupo Gallego de Investigaciones Oncológicas) Recruiting
Santiago de Compostela, La Coruña, Spain, 15701
Contact: Rafael López López, Coordinator         rllopez@seom.org    
Principal Investigator: José Carlos Méndez Méndez, MD            
Principal Investigator: Margarita Reboredo López, MD            
Principal Investigator: Juan de la Cámara Gómez, MD            
Principal Investigator: José Ramón Mel Lorenzo, MD            
Principal Investigator: Mercedes Salgado Fernández, MD            
Principal Investigator: Mónica Jorge Fernández, MD            
Principal Investigator: Rafael López, López            
Principal Investigator: Carlos Grande Ventura, MD            
Principal Investigator: Carlos Romero Reinoso, MD            
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: Grupo Gallego de Investigaciones Oncologicas ( Rafael López López )
Study ID Numbers: ML21154, 2007-003206-96
Study First Received: March 31, 2009
Last Updated: March 31, 2009
ClinicalTrials.gov Identifier: NCT00873353     History of Changes
Health Authority: Spain: Spanish Agency of Medicines

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

Study placed in the following topic categories:
Antimetabolites
Erlotinib
Capecitabine
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Protein Kinase Inhibitors
Pancrelipase
Carcinoma
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

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

ClinicalTrials.gov processed this record on May 07, 2009