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Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00922896
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : November 20, 2012
Sponsor:
Collaborators:
Dong-A University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Information provided by (Responsible Party):
Jung Hun Kang, Gyeongsang National University Hospital

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
Study Start Date : June 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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 Hosptial, Chung-Ang University College of Medicine

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
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: November 20, 2012
Last Verified: November 2012

Keywords provided by Jung Hun Kang, 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 Hydrochloride
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors