Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborators:
Dong-A University Hospital
Chung-Ang University Hospital
Information provided by (Responsible Party):
Jung Hun Kang, Gyeongsang National University Hospital
ClinicalTrials.gov Identifier:
NCT00922896
First received: June 2, 2009
Last updated: November 18, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to determine the response rate of gemcitabine, cisplatin and erlotinib in metastatic pancreatic cancer.


Condition Intervention Phase
Metastatic Pancreatic Cancer
Drug: Gemcitabine, Cisplatin, Erlotinib (Tarceva)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Gyeongsang National University Hospital:

Primary Outcome Measures:
  • To assess the response rate associated with gemcitabine, erlotinib and cisplatin in patients with advanced pancreatic cancer [ Time Frame: Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: June 2009
Study Completion Date: May 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GPE
Gemcitabine-Cisplatin-Erlotinib
Drug: Gemcitabine, Cisplatin, Erlotinib (Tarceva)
  • Erlotinib 100 mg po q d daily AND
  • Gemcitabine 1000 mg/m² with 250 mL of normal saline intravenously infusion over 30 mins on Day 1, 8
  • Cisplatin 25 mg/m2 with 150 mL of normal saline intravenously infusion over 60 mins on D1,8

Every 3 weeks


  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age older than 18
  • Younger than 75
  • ECOG performance status 0 or 1
  • Histologically confirmed adenocarcinoma of the pancreas
  • Metastatic pancreatic cancer
  • No prior chemotherapy for metastatic pancreatic cancer
  • A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)

Exclusion Criteria:

  • A patient with no measurable disease
  • A patient who received previous palliative chemotherapy for pancreatic cancer
  • A patient with locally advanced pancreatic cancer
  • A patient who received adjuvant chemotherapy for pancreatic cancer within 1 year
  • A patient with previous active or passive immunotherapy
  • A pregnant or lactating patient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922896

Locations
Korea, Republic of
Dong-A University Hospital
Busan, Korea, Republic of, 602-715
Gyeongsang Unversity Hospital
JinJU, Korea, Republic of
Chung-Ang University Hospital
Seoul, Korea, Republic of, 156-755
Sponsors and Collaborators
Gyeongsang National University Hospital
Dong-A University Hospital
Chung-Ang University Hospital
  More Information

No publications provided by Gyeongsang National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jung Hun Kang, Associate Professor, Gyeongsang National University Hospital
ClinicalTrials.gov Identifier: NCT00922896     History of Changes
Other Study ID Numbers: Gyeongsang-001
Study First Received: June 2, 2009
Last Updated: November 18, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Gyeongsang National University Hospital:
Gemcitabine
Cisplatin
Erlotinib

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
Cisplatin
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014