Quinacrine-Capecitabine Combinatorial Therapy for Advanced Stage Colorectal Adenocarcinoma

• Status: Terminated
• Trial end date: 2019-08-09
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fox Chase Cancer Center; Milton S. Hershey Medical Center
• Treatments: Capecitabine; Quinacrine

Criteria

Inclusion Criteria:

• Patients much have histologically confirmed adenocarcinoma of the colon or rectum.

• Patients must have measurable recurrence or metastases in the liver and/or lungs.

• Patients must have prior chemotherapy for advanced colorectal cancer and have previously received both an oxaliplatin and an irinotecan based regimen.

• Age > 18 years.

• Life expectancy greater than 4 weeks.

• ECOG performance status <3.

• Patients must have normal organ and marrow function.

• Patients must be able to swallow capsules.

• Patients must be able to understand and willing to sign a written informed consent document.

• Patients are included regardless of KRAS/BRAF status.

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

• Patients may not be receiving any other investigational agent.

• Patients with know brain metastases should be excluded from this clinical trial because they often develop progressive neurological dysfunction that would confound the evaluation of neurologic and other adverse events.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to quinacrine, capecitabine or fluorouracil.

• The concomitant use of quinacrine and primaquine is contraindicated.

• Uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Pregnant women are excluded from this study.

• Patients with a baseline creatinine clearance of < 50 mL/min.

• Patients must be currently not treated with quinacrine or drugs related to quinacrine.

• Patients who require anti-arrhythmic treatment with amiodarone or any drug with a quinidine-like effect on the heart or who have history of a malignant ventricular arrhythmia unless they have a functioning automatic implantable cardio defibrillator implanted.

• Patients who have a history of noninfectious hepatitis or alcoholism.

• Patients with a lifetime history of porphyria or psoriasis because it can exacerbate these conditions.

• Patients with documented glucose-6-phosphate dehydrogenase deficiency.

• Patients with a lifetime history of seizure disorder.

• Patients with a lifetime history of dermatitis as an allergic/toxic reaction to any medication.

• Patients with know dihydropyrimidine dehydrogenase deficiency.