NCT01844076

Quinacrine-Capecitabine Combinatorial Therapy for Advanced Stage Colorectal Adenocarcinoma

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Colorectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Quinacrine and Capecitabine	The Phase I portion of the 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.

Timeline

• Start date: 2016-01-14
• Primary completion: 2019-08-09
• Completion: 2019-08-09
• First posted: 2013-05-01
• Last updated: 2021-03-25
• Results posted: 2021-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study