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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00922896 |
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Date of registration:
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02/06/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
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Scientific title:
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A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00922896 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metastatic Pancreatic Cancer
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Intervention(s)
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Drug: Gemcitabine, Cisplatin, Erlotinib (Tarceva)
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Primary Outcome(s)
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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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Secondary ID(s)
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Gyeongsang-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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