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Etanercept and Gemcitabine in Patients With Advanced, Chemotherapy Naive Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201838
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : August 14, 2015
Last Update Posted : November 30, 2017
Immunex Corporation
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center

Brief Summary:

The aims of this protocol are:

  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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Adenocarcinoma Drug: Gemcitabine Drug: Etanercept Phase 1 Phase 2

Detailed Description:

Rationale: The standard treatment for pancreatic cancer is gemcitabine. This study combines gemcitabine with etanercept, a drug that binds with tumor necrosis factor (TNF) molecules and blocks their activity through inhibiting their interaction with cell surface TNF receptors. TNF is the name for a protein in the body that often helps fight foreign substances. However, research suggests that pancreatic tumors develop resistance to TNF and then use it to support cancer growth. Combining etanercept, a TNF inhibitor, with gemcitabine is a novel approach to advanced pancreatic cancer. Because etanercept has not been tested in combination with gemcitabine, a Phase I study will be conducted first to identify the safest dosage of etanercept, and then a Phase II study will evaluate the efficacy of this combination.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Etanercept and Gemcitabine in Patients With Advanced Stage and Chemotherapy Naive Pancreatic Adenocarcinoma
Study Start Date : July 2001
Actual Primary Completion Date : October 2006
Actual Study Completion Date : May 2007

Arm Intervention/treatment
Experimental: Arm I
Patients received entanercept 25 mg subcutaneously twice weekly with gemcitabine.
Drug: 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.
Other Name: Gemzar®

Drug: 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 Name: Enbrel

Active Comparator: 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.
Drug: 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.
Other Name: Gemzar®

Primary Outcome Measures :
  1. Anti-tumor Effect as Measured by the Proportion of Patients Free of Disease-progression at Six Months After Treatment Initiation [ Time Frame: up to 6 months ]
    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Percentages were calculated by a Kaplan Meier analysis.

Secondary Outcome Measures :
  1. Number of Patients With Response [ Time Frame: up to 12 months ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  2. Percentage of Patients With Clinical Benefit Response [ Time Frame: Up to 12 months ]
    A clinical benefit was defined by the improvement of at least one parameter over at least 4 weeks, without worsening of any other parameter (change in weight, ECOG performance status, Quality of life).

  3. Median Overall Survival Rates for Patients [ Time Frame: up to 1 year ]
    Median survival is defined as the time of initiation of the first dose of intervention to the date of death

  4. Serial Levels of TNF (Tumor Necrosis Factor) and Other Inflammatory Cytokines [ Time Frame: up to 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have pathological diagnosis recurring or metastatic Pancreatic Adenocarcinoma
  • No prior chemotherapy, immunology treatments or hormonal treatments
  • Measurable disease
  • Must be >18 years old

Inclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00201838

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United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Immunex Corporation
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Principal Investigator: Miguel Villalona Ohio State University
Additional Information:
Publications of Results:
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Responsible Party: Ohio State University Comprehensive Cancer Center Identifier: NCT00201838    
Other Study ID Numbers: OSU-0041
First Posted: September 20, 2005    Key Record Dates
Results First Posted: August 14, 2015
Last Update Posted: November 30, 2017
Last Verified: November 2017
Keywords provided by Ohio State University Comprehensive Cancer Center:
Advanced Stage
Chemotherapy Naive
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents