- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19011
- Fox Chase Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Phase I Level -2
Phase I (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. Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose. Group 1: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg once per day (days 1-21) for a 21 day cycle |
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.
Other Names:
|
EXPERIMENTAL: Phase I Level -1
Phase I (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. Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose. Group 1: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle |
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.
Other Names:
|
EXPERIMENTAL: Phase I Level 0
Group 3: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), quinacrine at a dose of 200 mg twice a day (days 1-21) for a 21 day cycle
|
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.
Other Names:
|
EXPERIMENTAL: Phase II
Phase II will use the treatment outlined in phase I, using the recommended phase II dose (RP2D) derived from Phase I. Patients will receive capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), quinacrine at a dose of 100 mg twice per day (days 1-21) for a 21 day cycle |
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase I - Number of Participants Who Experienced Dose Limiting Toxicities and Adverse Reactions
Time Frame: One year
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Establish the tolerability of both agents in combination when used at established clinical doses.
The objective is to determine toxicities and adverse reactions of patients in each group with different dose levels to find the maximum tolerated dose (MTD).
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One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase II - Rate of Response
Time Frame: 2-3 years
|
Determine rate of response in patients receiving quinacrine in combination with capecitabine.
Using Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) complete response (CR) is a disappearance of all target lesions, partial response (PR) is at least 30% decrease in the sum of diameters of target lesions, and overall response is the number of patients who experience a complete response or partial response.
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2-3 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase II - Time to Progression (TTP)
Time Frame: 2-3 years
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Determine time to progression from start of treatment in patients receiving quinacrine in combination with capecitabine.
Using Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1), progression is defined as a 20% increase in sum of target lesions, with at least a 5 mm absolute increase.
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2-3 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Crystal S. Denlinger, MD, Fox Chase Cancer Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Antinematodal Agents
- Anthelmintics
- Antiplatyhelmintic Agents
- Anticestodal Agents
- Capecitabine
- Quinacrine
Other Study ID Numbers
- GI-078
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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