Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Filters applied. Clear all
Clinical Trial
. Sep-Oct 2014;14(5):398-402.
doi: 10.1016/j.pan.2014.07.003. Epub 2014 Jul 18.

A Phase II, Open-Label, Multicenter Study to Evaluate the Antitumor Efficacy of CO-1.01 as Second-Line Therapy for Gemcitabine-Refractory Patients With Stage IV Pancreatic Adenocarcinoma and Negative Tumor hENT1 Expression

Affiliations
Free PMC article
Clinical Trial

A Phase II, Open-Label, Multicenter Study to Evaluate the Antitumor Efficacy of CO-1.01 as Second-Line Therapy for Gemcitabine-Refractory Patients With Stage IV Pancreatic Adenocarcinoma and Negative Tumor hENT1 Expression

D Li et al. Pancreatology. .
Free PMC article

Abstract

Background: Nucleotide transporters such as human equilibrative nucleoside transporter-1 (hENT1) play a major role in transporting gemcitabine into cells. CO-1.01 (gemcitabine-5'-elaidate) is a novel cytotoxic agent consisting of a fatty acid derivative of gemcitabine, which is transported intracellularly independent of hENT1. CO-1.01 was postulated to have efficacy as a second-line treatment in gemcitabine-refractory pancreatic adenocarcinoma in patients with negative tumor hENT1 expression.

Methods: Eligibility criteria included patients with either a newly procured or archival biopsy tumor confirming the absence of hENT1 and either gemcitabine-refractory metastatic pancreas adenocarcinoma or with progression of disease following resection during or within 3 months of adjuvant gemcitabine therapy. Patients were treated with intravenous infusion of CO-1.01 dosed at 1250 mg/m(2) on Days 1, 8, and 15 of a 4-week cycle. The primary end point was disease control rate (DCR).

Results: Nineteen patients were enrolled of which 18 patients were evaluable for efficacy assessment. Thirteen patients (68%) had liver metastases, 6 (32%) had lymph node metastases, and 10 (53%) had lung metastases. Two of 18 patients (11%) achieved disease control. The median survival time was 4.3 (95% CI 2.1-8.1) months. All patients experienced at least one treatment-related adverse event with the majority of events being mild or moderate.

Conclusion: This study did not meet its primary endpoint and no efficacy signal was identified for CO-1.01 in treating progressive metastatic pancreas adenocarcinoma.

Keywords: Biomarker; CO-1.01; Disease-control rate; Gemcitabine-refractory; Pancreas adenocarcinoma; hENT1.

Similar articles

See all similar articles

Cited by 4 articles

Publication types

MeSH terms

Feedback