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Quinacrine-Capecitabine Combinatorial Therapy for Advanced Stage Colorectal Adenocarcinoma

Colorectal Adenocarcinoma Clinical Trial

Official title:
Quinacrine-Capecitabine Combinatorial Therapy for Advanced Stage Colorectal Adenocarcinoma:A Phase I/II Investigator-Initiated Clinical Trial

Clinical Trial Summary

Establish the tolerability and safety of aimed dose of both quinacrine and capecitabine in combination to treat patients with advanced colorectal adenocarcinoma.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01844076
Study type Interventional
Source Fox Chase Cancer Center
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date January 14, 2016
Completion date August 9, 2019
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