Back to resultsTrial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
Primary Purpose
Metastatic Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gemcitabine, Cisplatin, Erlotinib (Tarceva)
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring Gemcitabine, Cisplatin, Erlotinib
Eligibility 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
Sites / Locations
- Dong-A University Hospital
- Gyeongsang Unversity Hospital
- Chung-Ang University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GPE
Arm Description
Gemcitabine-Cisplatin-Erlotinib
Outcomes
Primary Outcome Measures
To assess the response rate associated with gemcitabine, erlotinib and cisplatin in patients with advanced pancreatic cancer
Secondary Outcome Measures
Full Information
NCT ID
NCT00922896
First Posted
June 2, 2009
Last Updated
November 18, 2012
Sponsor
Gyeongsang National University Hospital
Collaborators
Dong-A University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00922896
Brief Title
Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
Official Title
A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gyeongsang National University Hospital
Collaborators
Dong-A University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the response rate of gemcitabine, cisplatin and erlotinib in metastatic pancreatic cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer
Keywords
Gemcitabine, Cisplatin, Erlotinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GPE
Arm Type
Experimental
Arm Description
Gemcitabine-Cisplatin-Erlotinib
Intervention Type
Drug
Intervention Name(s)
Gemcitabine, Cisplatin, Erlotinib (Tarceva)
Intervention Description
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Gyeongsang Unversity Hospital
City
JinJU
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22302349
Citation
Hwang IG, Jang JS, Oh SY, Lee S, Kwon HC, Lee GW, Go S, Kang MH, Cha YJ, Kang JH. A phase II trial of Erlotinib in combination with gemcitabine and cisplatin in advanced pancreatic cancer. Invest New Drugs. 2012 Dec;30(6):2371-6. doi: 10.1007/s10637-012-9792-z.
Results Reference
derived
Learn more about this trial
Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
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