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

ClinicalTrials.gov processed this record on November 25, 2014