Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer
NCT ID: NCT01010945
Last Updated: 2024-11-21
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
PHASE1
19 participants
INTERVENTIONAL
2010-02-03
2012-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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erlotinib, gemcitabine, nab-paclitaxel
Patients receive the following treatment in 28-day cycles: 1) erlotinib: orally once daily from days 1 through 28 continuous dosing; 2) gemcitabine (following nab-paclitaxel): intravenously over 30 minutes on days 1, 8 and 15 every 28 days; and 3) nab-paclitaxel: intravenously over 30 minutes on days 1, 8 and 15 every 28 days.
erlotinib
administered orally
gemcitabine
administered intravenously
nab-paclitaxel
administered intravenously
Interventions
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erlotinib
administered orally
gemcitabine
administered intravenously
nab-paclitaxel
administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Predicted life expectancy of \>= 12 weeks
* Previous surgery
* Histologically or cytologically confirmed, measurable, locally advanced, unresectable or metastatic pancreatic adenocarcinoma
* No prior therapy for pancreatic cancer
* Adequate organ and marrow function
* Absolute neutrophil count \>= 1.5 x 10\^9/L
* Platelets \>= 100 x 10\^9/L
* Total bilirubin \<= institutional upper limits of normal
* AST (SGOT)/ALT(SGPT) \<= 2 x institutional upper limits of normal
* Serum creatinine \<= 1.5 x upper limits of normal
* Negative pregnancy test
* Informed consent
* Patient must agree not to smoke while on study
Exclusion Criteria
* Active or uncontrolled infections or serious illness or medical conditions that could interfere with the patient's ongoing participation in study
* History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
* History of smoking within the previous 14 days before enrollment or positive cotinine test at baseline
* Pregnant or breast-feeding females
* Symptomatic brain metastases that are not stable, that require steroids, that are potentially life-threatening, or that have required radiation within the last 14 days
* History of allergic reactions attributed to compounds of similar chemical or biological composition to the study drugs
18 Years
ALL
No
Sponsors
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OSI Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Desert Comprehensive Cancer Center
Palm Springs, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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09PAN01
Identifier Type: OTHER
Identifier Source: secondary_id
OSI-774-108
Identifier Type: -
Identifier Source: org_study_id
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