Quinacrine-Capecitabine Combinatorial Therapy for Advanced Stage Colorectal Adenocarcinoma:
Because of the well published safety profiles of both quinacrine and capecitabine, the Phase
I portion of our study will aim to determine the tolerability of both agents in combinations
when used at established clinical doses. This portion of the study will more closely
resemble a pilot study or feasibility study rather than a dose escalation Phase I trial.
The objective is to determine toxicities and adverse reactions, not a maximally tolerated
dose. The investigators hypothesize that there will be no toxic interactions at the
pharmacokinetic or pharmacodynamic level, and want to know the feasibility of using
quinacrine and capecitabine at their respective recommended single agent doses. Because
capecitabine is already regarded as standard treatment for colorectal cancer, the
investigators will begin the study with a full dose of capecitabine combined with a slightly
lower dose of quinacrine. If the safety-interim analysis does not detect an excess of
toxicity, then subsequent patients will be enrolled using the full dose of both drugs.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I - Tolerability and Safety
Establish the tolerability of both agents in combination when used at established clinical doses. The objective is to determine toxicities and adverse reactions.
Wafik S. El-Deiry, MD, PhD
Milton S. Hershey Medical Center
United States: Food and Drug Administration
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