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Main
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Note: This record shows only the 20 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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18 February 2013 |
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Main ID: |
NCT00733746 |
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Date of registration:
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12/08/2008 |
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Primary sponsor: |
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Public title:
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Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
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Scientific title:
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A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients With Operable Pancreatic Adenocarcinoma |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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123 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00733746 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Peter W.T. Pisters, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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M.D. Anderson Cancer Center |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreatic head or
uncinate process
- No tumors of the pancreatic neck, body, or tail
- No evidence of neuroendocrine tumors, duodenal adenocarcinoma, or ampullary
adenocarcinoma
- Localized, potentially resectable* tumor by chest x-ray or CT scan and abdominal CT
scan or MRI, as defined by the following:
- No evidence of tumor extension to the celiac axis, hepatic artery, or superior
mesenteric artery
- No evidence of tumor encasement or occlusion of the superior mesenteric vein
(SMV) or the SMV/portal vein confluence
- No evidence of visceral or peritoneal metastases NOTE: *Patients with borderline
resectable or marginally resectable pancreatic cancer are not eligible.
PATIENT CHARACTERISTICS:
- ECOG or Zubrod performance status 0-1
- WBC = 2,000/mm³
- ANC = 1,500/mm³
- Platelet count = 100,000/mm³
- Total bilirubin = 2.5 mg/dL
- ALT and AST = 2.5 times upper limit of normal
- Albumin = 3.2 g/dL
- Serum creatinine = 1.5 mg/dL OR creatinine clearance = 50 mL/min
- Baseline weight loss = 15% of premorbid weight
- No active infection requiring intravenous antibiotics
- No other malignancy within the past 5 years except for nonmelanoma skin cancer or in
situ cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No prior EGFR-targeted therapy
- No prior therapy for pancreatic cancer
- No other concurrent investigational or commercial agents or therapies for pancreatic
cancer
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pancreatic Cancer
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Intervention(s)
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Drug: erlotinib hydrochloride
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Drug: gemcitabine hydrochloride
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Genetic: gene expression analysis
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Genetic: polymorphism analysis
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Genetic: RNA analysis
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Other: laboratory biomarker analysis
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Procedure: adjuvant therapy
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Procedure: neoadjuvant therapy
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Procedure: therapeutic conventional surgery
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Primary Outcome(s)
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Overall survival at 2 years
[Time Frame: No]
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Secondary Outcome(s)
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Adverse event profile
[Time Frame: Yes]
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Molecular and genetic profiles
[Time Frame: No]
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Relapse/progression-free survival
[Time Frame: No]
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Resection rate
[Time Frame: No]
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Response rate
[Time Frame: No]
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Secondary ID(s)
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ACOSOG-Z5041
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CDR0000609871
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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