Etanercept and Gemcitabine in Patients With Advanced, Chemotherapy Naive Pancreatic Adenocarcinoma
NCT ID: NCT00201838
Last Updated: 2017-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
38 participants
INTERVENTIONAL
2001-07-31
2007-05-31
Brief Summary
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1. To study the safety and tolerability of the combination of etanercept and gemcitabine in patients with advanced pancreatic cancer:
2. To estimate the anti-tumor effect as measured by the proportion of patients free of disease-progression at six months after treatment initiation.
Detailed Description
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Purpose: This study is evaluating the safety of etanercept and gemcitabine for advanced pancreatic cancer in Phase I, and the efficacy of etanercept and gemcitabine for this condition in Phase II. TNF and other inflammatory markers will also be measured in the study.
Treatment: Patients in this study will receive gemcitabine and etanercept. Gemcitabine will be administered through an intravenous infusion weekly for seven weeks followed by one week of rest. Additional treatments with gemcitabine will be given for three weeks followed by one week of rest. Patients will administer etanercept to themselves through a small injection underneath the skin twice each week. Six patients will initially be enrolled in Phase I. If severe side effects appear in at least two patients in Phase I, then additional patients will be enrolled and treated with lower dosages of gemcitabine. When the treatments do not produce unacceptable side effects, the Phase I portion of the study will end and Phase II will begin enrolling patients. Patients in the Phase II portion of the study will also receive gemcitabine and etanercept at the safest dosages identified in Phase I. Several tests and exams will be given throughout both portions of the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I
Patients received entanercept 25 mg subcutaneously twice weekly with gemcitabine.
Gemcitabine
The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.
Etanercept
Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study.
Arm II
Patients with pancreatic cancer for which treatment with gemcitabine as a single agent is planned will be asked to participate in this trial as a control group.
Gemcitabine
The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.
Interventions
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Gemcitabine
The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.
Etanercept
Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior chemotherapy, immunology treatments or hormonal treatments
* Measurable disease
* Must be \>18 years old
* ONLY CONTROL ARM IS OPEN TO ACCRUAL
* Pregnant and nursing mothers.
* Psychiatric disorders that would interfere with consent ability.
* Patients with known brain or leptomeningeal disease.
* Patients with history of myocardial infarction with in six previous months.
* Any concurrent illness that would constitute a hazard to participation in study.
* Known sensitivity to gemcitabine or etanercept.
* Prior treatment with etanercept.
18 Years
ALL
No
Sponsors
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Immunex Corporation
INDUSTRY
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Miguel Villalona
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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References
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Wu C, Fernandez SA, Criswell T, Chidiac TA, Guttridge D, Villalona-Calero M, Bekaii-Saab TS. Disrupting cytokine signaling in pancreatic cancer: a phase I/II study of etanercept in combination with gemcitabine in patients with advanced disease. Pancreas. 2013 Jul;42(5):813-8. doi: 10.1097/MPA.0b013e318279b87f.
Related Links
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Jamesline
Other Identifiers
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OSU-0041
Identifier Type: -
Identifier Source: org_study_id