NCT00201838 is a Phase 1/Phase 2 clinical trial of Gemcitabine in Pancreatic Neoplasms, sponsored by Ohio State University Comprehensive Cancer Center.

Who is sponsoring NCT00201838?

NCT00201838 is sponsored by Ohio State University Comprehensive Cancer Center.

What drugs are being tested in NCT00201838?

Interventions in NCT00201838: Gemcitabine, Etanercept.

What condition does NCT00201838 study?

NCT00201838 studies Pancreatic Neoplasms, Adenocarcinoma.

Is NCT00201838 still recruiting?

NCT00201838 is currently completed. Last updated 28 November 2017.

Are results published for NCT00201838?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-11-28 · How we verify

NCT00201838

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase I/II Study of Etanercept and Gemcitabine in Patients With Advanced Stage and Chemotherapy Naive Pancreatic Adenocarcinoma

Completed Phase 1/Phase 2 Results posted Last updated 28 November 2017

What this trial tests

Phase 1/Phase 2 trial testing Gemcitabine in Pancreatic Neoplasms in 38 participants. Completed in 1 May 2007.

Timeline

1 July 2001

Primary endpoint
1 October 2006

1 May 2007

Quick facts

Lead sponsor	Ohio State University Comprehensive Cancer Center
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	1 July 2001
Primary completion	1 October 2006
Estimated completion	1 May 2007
Sites	1 location across United States

Drugs / interventions tested

Gemcitabine (gemcitabine) — full drug profile →
Etanercept (etanercept) — full drug profile →

Conditions studied

Pancreatic Neoplasms — all drugs for Pancreatic Neoplasms →
Adenocarcinoma — all drugs for Adenocarcinoma →

Sponsor

Ohio State University Comprehensive Cancer Center

Who can join

18 and older, any sex, with Pancreatic Neoplasms or Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Inflammation and tumor progression: signaling pathways and targeted intervention.
Zhao H, Wu L, Yan G, Chen Y, et al · · 2021 · cited 1932× · PMID 34248142 · DOI 10.1038/s41392-021-00658-5
Targeting cytokine and chemokine signaling pathways for cancer therapy.
Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3
Disrupting cytokine signaling in pancreatic cancer: a phase I/II study of etanercept in combination with gemcitabine in patients with advanced disease.
Wu C, Fernandez SA, Criswell T, Chidiac TA, et al · · 2013 · cited 57× · PMID 23429495 · DOI 10.1097/mpa.0b013e318279b87f
The Role of Dysfunctional Adipose Tissue in Pancreatic Cancer: A Molecular Perspective.
Brocco D, Florio R, De Lellis L, Veschi S, et al · · 2020 · cited 28× · PMID 32659999 · DOI 10.3390/cancers12071849
Aging and immunotherapies: New horizons for the golden ages.
Hamilton JAG, Henry CJ. · · 2020 · cited 17× · PMID 35874875 · DOI 10.1002/aac2.12014
Oncogenic <i>KRAS</i>-Induced Feedback Inflammatory Signaling in Pancreatic Cancer: An Overview and New Therapeutic Opportunities.
Bansod S, Dodhiawala PB, Lim KH. · · 2021 · cited 17× · PMID 34771644 · DOI 10.3390/cancers13215481
Cancer-triggered systemic disease and therapeutic targets.
Cao Y. · · 2024 · cited 7× · PMID 38482486 · DOI 10.1007/s44178-024-00077-w

Verify or expand the search:

Other trials of Gemcitabine

Trials testing the same drug.

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NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand · Phase 2 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting

Other recruiting trials for Pancreatic Neoplasms

Currently open trials in the same condition.

NCT07504471 — Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen and Programmed Death-1 (PD-1) Inhib · Phase 2 · recruiting
NCT07139236 — Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD · recruiting
NCT06885697 — Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Includi · Phase 1 · recruiting
NCT06939023 — Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3) · NA · recruiting
NCT06953193 — Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia · NA · recruiting

Other Ohio State University Comprehensive Cancer Center trials

Trials by the same sponsor.

NCT06816979 — Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell · NA · not yet recruiting
NCT07529483 — Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cysts · Phase 2 · not yet recruiting
NCT07455513 — A Novel Tobacco Cessation Resource for Smokers With a Diagnosed or Suspected Thoracic Cancer · NA · not yet recruiting
NCT07217990 — Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer · Phase 1, PHASE2 · not yet recruiting
NCT07503925 — THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health · Phase 4 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00201838 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center
Last refreshed: 28 November 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00201838.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing