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

NCT00201838 | Completed Phase 1 Results DMC

• 1 other identifier: OSU-0041
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this protocol are:

1. 1.To study the safety and tolerability of the combination of etanercept and gemcitabine in patients with advanced pancreatic cancer:
2. 2.To estimate the anti-tumor effect as measured by the proportion of patients free of disease-progression at six months after treatment initiation.

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Keywords

Advanced Stage; Chemotherapy Naive

Outcome Measures

Primary Outcomes (1)

• Anti-tumor Effect as Measured by the Proportion of Patients Free of Disease-progression at Six Months After Treatment Initiation

  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.

  up to 6 months

Secondary Outcomes (4)

• Number of Patients With Response

  up to 12 months

• Percentage of Patients With Clinical Benefit Response

  Up to 12 months

• Median Overall Survival Rates for Patients

  up to 1 year

• Serial Levels of TNF (Tumor Necrosis Factor) and Other Inflammatory Cytokines

  up to 6 months

Study Arms (2)

Arm I

EXPERIMENTAL

Patients received entanercept 25 mg subcutaneously twice weekly with gemcitabine.

Drug: Gemcitabine; Drug: Etanercept

Arm II

ACTIVE COMPARATOR

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

Interventions

Gemcitabine DRUG

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.

Also known as: Gemzar®

Arm I; Arm II

Etanercept DRUG

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.

Also known as: Enbrel

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Immunex Corporation: collaborator

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 23429495 RESULT

Related Links

• Jamesline

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Interventions

Gemcitabine; Etanercept

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Limitations and Caveats

The interpretation of the results for this study is limited by the relatively small patient sample and correlative samples.

Results Point of Contact

• Title: Miguel Villalona-Calero, MD
• Organization: The Ohio State Unversity Comprehensive Cancer Center

Miguel.Villalona@osumc.edu

614-293-5484

Study Officials

• Miguel Villalona

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2001
• Primary Completion: October 1, 2006
• Study Completion: May 1, 2007
• Last Updated: November 30, 2017
• Results First Posted: August 14, 2015

Record last verified: 2017-11

Locations

US (1)