Quinacrine-Capecitabine Combinatorial Therapy for Advanced Stage Colorectal Adenocarcinoma

Stopped early · Phase 1/Phase 2

Conditions studied: Colorectal Adenocarcinoma

In brief

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

Key facts

Study ID

NCT01844076

Run by

Fox Chase Cancer Center

People needed

19

Starts

2016-01-14

Expected to finish

2019-08-09

Last updated by the study team

2021-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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