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| ID | Type | Description | Link |
|---|---|---|---|
| UCI 06-30 | |||
| N01CN35160 | U.S. NIH Grant/Contract | View source | |
| CDR0000547235 | Registry Identifier | PDQ (Physician Data Query) |
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The protocol has been completed prematurely (e.g., due to poor accrual, insufficient drug supply, IND closure).
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Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This phase II trial is studying how well erlotinib hydrochloride works in treating patients with pancreatic cancer that can be removed by surgery
PRIMARY OBJECTIVES:
I. To test the hypothesis that the activated epidermal growth factor receptor (EGFR) signal transduction biomarker Mucin 5AC (MUC5AC) protein expression within intraductal pancreatic mucinous neoplasm (IPMN) lesions will have greater than zero absolute mean decrease from baseline comparing pre and post 21-42 days of Erlotinib (erlotinib hydrochloride) administration at 100mg orally (PO) once daily (QD).
SECONDARY OBJECTIVES:
I. To test the hypothesis that other correlative IPMN EGF inducible biomarkers will have greater than zero absolute mean decrease from baseline pre and post Erlotinib 100mg PO QD therapy.
II. Safety of Erlotinib treatment. III. To determine Erlotinib pharmacokinetic concentration in plasma and pancreatic tissue at the 100mg/day dose up to 42 days of therapy.
OUTLINE:
Patients receive erlotinib hydrochloride PO QD for 21-42 days in the absence of disease progression or unacceptable toxicity. Patients then undergo to pancreatectomy.
After completion of study treatment, patients are followed up at 4-20 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (enzyme inhibitor therapy) | Experimental | Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib hydrochloride | Drug | Given PO |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment | Number of participants showed a reduction in number of positive IPMN cells and staining intensity after treatment | Pre-treatment and post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Calculated Concentration - OSI-774 (ng/mL) | Plasma concentration levels of Erlotinib (OSI-774) | 20 weeks |
| Pancreas Calculated Concentration - OSI-774 (ng/g) | Pancreatic tissue concentration levels of Erlotinib (OSI-774) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven M Lipkin, MD,PhD | Weill Cornell College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Medical Center At Irvine-Orange Campus | Orange | California | 92868 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14520092 | Result | Armstrong WB, Wan XS, Kennedy AR, Taylor TH, Meyskens FL Jr. Development of the Bowman-Birk inhibitor for oral cancer chemoprevention and analysis of Neu immunohistochemical staining intensity with Bowman-Birk inhibitor concentrate treatment. Laryngoscope. 2003 Oct;113(10):1687-702. doi: 10.1097/00005537-200310000-00007. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Enzyme Inhibitor Therapy) | Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery. erlotinib hydrochloride: Given PO conventional surgery: Undergo pancreatectomy immunohistochemistry staining method: Correlative studies protein expression analysis: Correlative studies biopsy: Correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| conventional surgery | Procedure | Undergo pancreatectomy |
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| immunohistochemistry staining method | Other | Correlative studies |
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| protein expression analysis | Genetic | Correlative studies |
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| biopsy | Procedure | Correlative studies |
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| pharmacological study | Other | Correlative studies |
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| laboratory biomarker analysis | Other | Correlative studies |
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| 20 weeks |
| Plasma Calculated Concentration - OSI-420 (ng/mL) | Plasma concentration levels of Erlotinib (OSI-420) | 20 weeks |
| Pancreas Calculated Concentration - OSI-420 (ng/g) | Pancreatic tissue concentration levels of Erlotinib (OSI-420) | 20 weeks |
| Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above | The worst grade of pre-listed toxicity will be summarized by participant and by visit for each treatment group. Descriptive statistics (frequencies and percents) will be used to summarize data and hypotheses about group differences will be tested where appropriate. | Up to 20 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Enzyme Inhibitor Therapy) | Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery. erlotinib hydrochloride: Given PO conventional surgery: Undergo pancreatectomy immunohistochemistry staining method: Correlative studies protein expression analysis: Correlative studies biopsy: Correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment | Number of participants showed a reduction in number of positive IPMN cells and staining intensity after treatment | Posted | Number | participants | Pre-treatment and post-treatment |
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| Secondary | Plasma Calculated Concentration - OSI-774 (ng/mL) | Plasma concentration levels of Erlotinib (OSI-774) | Posted | Mean | Standard Deviation | ng/mL | 20 weeks |
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| Secondary | Pancreas Calculated Concentration - OSI-774 (ng/g) | Pancreatic tissue concentration levels of Erlotinib (OSI-774) | Posted | Mean | Standard Deviation | ng/g | 20 weeks |
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| Secondary | Plasma Calculated Concentration - OSI-420 (ng/mL) | Plasma concentration levels of Erlotinib (OSI-420) | Posted | Mean | Standard Deviation | ng/mL | 20 weeks |
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| Secondary | Pancreas Calculated Concentration - OSI-420 (ng/g) | Pancreatic tissue concentration levels of Erlotinib (OSI-420) | Posted | Mean | Standard Deviation | ng/g | 20 weeks |
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| Secondary | Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above | The worst grade of pre-listed toxicity will be summarized by participant and by visit for each treatment group. Descriptive statistics (frequencies and percents) will be used to summarize data and hypotheses about group differences will be tested where appropriate. | Posted | Number | participants | Up to 20 weeks |
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All adverse events are reported and docuemted during the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Enzyme Inhibitor Therapy) | Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery. erlotinib hydrochloride: Given PO conventional surgery: Undergo pancreatectomy immunohistochemistry staining method: Correlative studies protein expression analysis: Correlative studies biopsy: Correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies | 0 | 6 | 5 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHEA | Gastrointestinal disorders | Non-systematic Assessment |
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| DIFFICULTY DIGESTING FOOD-UPPER GI | Gastrointestinal disorders | Non-systematic Assessment |
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| DRY EYES | Eye disorders | Non-systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| DRY SKIN ON BODY | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| DRY SKIN ON CHEEK AND CORNERS OF MOUTH | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| FATIGUE | General disorders | Non-systematic Assessment |
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| HEADACHE | Nervous system disorders | Non-systematic Assessment |
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| INSOMNIA | Psychiatric disorders | Non-systematic Assessment |
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| LEG, FOOT, ANKLE CRAMPS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| LOSS OF APPETITE | Gastrointestinal disorders | Non-systematic Assessment |
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| OUT OF RANGE LYMPHOCYTE VALUE-CLINICALLY SIGNIFICANT | Investigations | Non-systematic Assessment |
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| OUT OF RANGE NEUTROPHIL VALUE-CLINICALLY SIGNIFICANT | Investigations | Non-systematic Assessment |
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| OUT OF RANGE WBC VALUE-CLINICALLY SIGNIFICANT | Investigations | Non-systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Lipkin | Weill Cornell College of Medicine | 212-774-7160 | stl2012@med.cornell.edu |
| ID | Term |
|---|---|
| D000077779 | Pancreatic Intraductal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D013514 | Surgical Procedures, Operative |
| D003226 | Congresses as Topic |
| D007150 | Immunohistochemistry |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D003581 | Cytodiagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
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