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

This study has been completed.
Sponsor:
Collaborator:
Immunex Corporation
Information provided by (Responsible Party):
Miguel Villalona, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201838
First received: September 12, 2005
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Pancreatic Neoplasms
Adenocarcinoma
Drug: Gemcitabine
Drug: Etanercept
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • anti-tumor effect as measured by the proportion of patients free of disease-progression at six months after treatment initiation [ Time Frame: 2001-2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical Benefit Response as defined by pain intensity and analgesic use, [ Time Frame: 2001-2010 ] [ Designated as safety issue: No ]
  • change in weight, ECOG performance status, and quality of life [ Time Frame: 2001-2010 ] [ Designated as safety issue: Yes ]
  • Median survival and survival rates at 6 and 12 months [ Time Frame: 2001-2010 ] [ Designated as safety issue: No ]
  • serial levels of TNF and other inflammatory cytokines [ Time Frame: 2001-2010 ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: July 2001
Study Completion Date: May 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • ONLY CONTROL ARM IS OPEN TO ACCRUAL

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201838

Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Immunex Corporation
Investigators
Principal Investigator: Miguel Villalona Ohio State University
  More Information

Additional Information:
No publications provided by Ohio State University Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Miguel Villalona, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201838     History of Changes
Other Study ID Numbers: OSU-0041
Study First Received: September 12, 2005
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Advanced Stage
Chemotherapy Naive

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Gemcitabine
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Antiviral Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 30, 2014