Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
NCT ID: NCT00922896
Last Updated: 2012-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2009-06-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GPE
Gemcitabine-Cisplatin-Erlotinib
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
Interventions
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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 Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Dong-A University Hospital
OTHER
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
Gyeongsang National University Hospital
OTHER
Responsible Party
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Jung Hun Kang
Associate Professor
Locations
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Dong-A University Hospital
Busan, , South Korea
Gyeongsang Unversity Hospital
Jinju, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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Gyeongsang-001
Identifier Type: -
Identifier Source: org_study_id