A Phase I Open-Label, Ascending Dose Cohort Study of Gemcitabine Elaidate and Cisplatin in Patients With Advanced Solid Tumors Followed by an Expanded Cohort of Patients With Stage IIIb/IV NSCLC.
The chemotherapy doublet of cisplatin and gemcitabine is an effective regimen for solid
tumors including NSCLC. Entry of gemcitabine into tumor cells has been shown to be
dependent on specific membrane transporter proteins, particularly human equilibrative
nucleoside transporter 1 (hENT1). Patients with low tumor hENT-1 expression may respond
poorly to gemcitabine-containing chemotherapy. Gemcitabine elaidate (CO-1.01) is a fatty
acid derivative of gemcitabine, and can enter cells in the absence of hENT1. CO-1.01
therefore, may overcome hENT1-mediated resistance to gemcitabine.
CO-1.01 is currently being evaluated as a single agent in a pivotal randomized trial in 360
patients with metastatic pancreatic adenocarcinoma. The appropriate dose of CO-1.01 when
given as part of combination therapy with a platinum agent such as cisplatin is not yet
known. The objectives of this study are to:
- determine the maximum tolerated dose (MTD) of CO-1.01 when combined with a fixed dose
of cisplatin in patients with solid tumors
- select a recommended dose (RD) for dose expansion in patients with Stage IIIb/IV NSCLC
- explore clinical activity of CO-1.01 in patients with Stage IIIb/IV NSCLC
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose limiting toxicities (DLT)(Part 1)
From time taking first dose of CO-1.01 (Cycle 1 Day 1) through last day of Cycle 1 (Cycle 1 Day 21), an expected average of 6 weeks.
United States: Food and Drug Administration
|Florida Cancer Specialists||Fort Myers, Florida 33901|
|Tennessee Oncology||Nashville, Tennessee 37203|