Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
1 other identifier
interventional
22
1 country
3
Brief Summary
The purpose of this study is to determine the response rate of gemcitabine, cisplatin and erlotinib in metastatic pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2009
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 2, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedNovember 20, 2012
November 1, 2012
1.2 years
June 2, 2009
November 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the response rate associated with gemcitabine, erlotinib and cisplatin in patients with advanced pancreatic cancer
Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan
Study Arms (1)
GPE
EXPERIMENTALGemcitabine-Cisplatin-Erlotinib
Interventions
* 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 Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Dong-A University Hospital
Busan, 602-715, South Korea
Gyeongsang Unversity Hospital
Jinju, South Korea
Chung-Ang University Hospital
Seoul, 156-755, South Korea
Related Publications (1)
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.
PMID: 22302349DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 2, 2009
First Posted
June 17, 2009
Study Start
June 1, 2009
Primary Completion
August 1, 2010
Study Completion
May 1, 2011
Last Updated
November 20, 2012
Record last verified: 2012-11