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The Role of EGFR and KRAS in Pancreatic Cancer Patients Receiving Gemcitabine Combined With Erlotinib

This study is currently recruiting participants.
Verified June 2012 by Taipei Veterans General Hospital,Taiwan
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier:
NCT01608841
First received: May 28, 2012
Last updated: June 1, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to investigate the influence of epidermal growth factor receptor and KRAS mutations on the efficacy of erlotinib and gemcitabine in metastatic pancreatic cancer.


Condition Intervention Phase
Metastatic Pancreatic Cancer
 Drug: Erlotinib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Epidermal Growth Factor Receptor (EGFR) and the Downstream Gene KRAS in Pancreatic Cancer Patients Receiving Gemcitabine Combined With Erlotinib Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taipei Veterans General Hospital,Taiwan:

Primary Outcome Measures:
  • overall survival [ Time Frame: one day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • response rate [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
  • disease control rate [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • progression-free survival [ Time Frame: one day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: July 2005
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Gemcitabine Drug: Erlotinib
Erlotinib 100 mg 1# PO qd till disease progression
Other Name: Tarceva
Experimental: Gemcitabine plus erlotinib Drug: Erlotinib
Erlotinib 100 mg 1# PO qd till disease progression
Other Name: Tarceva

Detailed Description:

The influence of EGFR and KRAS mutations on the efficacy of treatment with and without erlotinib in metastatic pancreatic cancer is to be determined.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • metastatic chemotherapy-naïve pancreatic cancer patients
  • histologically confirmed
  • adequate samples for analysis
  • Karnofsky performance <= 2
  • absolute neutrophil count (ANC) >= 1,500/mm3
  • platelet count >= 100,000/mm3
  • serum creatinine <= 1.5 mg/dL
  • aspartate aminotransferase (AST)
  • alanine aminotransferase (ALT) < 5 times the upper limit of normal

Exclusion Criteria:

  • absence of any other malignancy or serious medical or psychological illness that would preclude informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608841

Contacts
Contact: Chung-Pin Li, MD +886-2-28757506 cpli@vghtpe.gov.tw

Locations
Taiwan
Division of Gastroenterology, Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Chung-Pin Li, MD     +886-2-28757506     cpli@vghtpe.gov.tw    
Principal Investigator: Chung-Pin Li, MD            
Sponsors and Collaborators
Taipei Veterans General Hospital,Taiwan
Investigators
Principal Investigator: Chung-Pin Li, MD, PhD Taipei Veterans General Hospital,Taiwan
Study Director: Yee Chao, MD,PhD Taipei Veterans General Hospital,Taiwan
  More Information

No publications provided

Responsible Party: vghtpe user, Attending Physician, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier: NCT01608841     History of Changes
Other Study ID Numbers: 98-01-34A
Study First Received: May 28, 2012
Last Updated: June 1, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Erlotinib
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013