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Monoclonal Antibodies
Hydroxychloroquine + FOLFIRI + Bevacizumab for Colorectal Cancer
Phase 2
Recruiting
Led By Eric Chen, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of study treatment to end of study, up to 48 months.
Awards & highlights
Study Summary
This trial tests a new chemo+drug combo to treat mCRC. Up to 155 patients will be screened, up to 31 will receive the combo until progression, side effects, etc.
Who is the study for?
This trial is for adults with metastatic colorectal cancer that can't be surgically removed, have a specific DTP-high signature, and haven't had treatment for their metastatic disease yet. They should be in good physical condition (ECOG 0-1), not pregnant or nursing, without certain blood disorders or eye diseases, and must not have had major surgery recently.Check my eligibility
What is being tested?
The study tests the combination of FOLFIRI-beva (5-FU, irinotecan, bevacizumab) with hydroxychloroquine on patients who haven't been treated before for their advanced colorectal cancer. It's a Phase II trial to see how well this combo works in those with high levels of a specific tumor marker called DTP-signature.See study design
What are the potential side effects?
Possible side effects include fatigue, diarrhea from FOLFIRI; hypertension and bleeding from Bevacizumab; and vision changes or muscle weakness due to Hydroxychloroquine. Each drug has its own set of potential side effects which may vary among individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start of study treatment to end of study, up to 48 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of study treatment to end of study, up to 48 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate
Secondary outcome measures
Incidences and severity of adverse events
Overall survival
Progression-free survival
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: High DTP-signatureExperimental Treatment5 Interventions
Take HCQ, 400 mg by mouth, twice daily. Receive FOLFIRI+bevacizumab (irinotecan 180 mg/m2, leucovorin 400 mg/m2, 5-FU 2400 mg/m2 over 46 - 48 hours, bevacizumab 5 mg/kg), intravenously, every 2 weeks
Group II: Low DTP-signatureActive Control4 Interventions
Receive FOLFIRI+bevacizumab (irinotecan 180 mg/m2, leucovorin 400 mg/m2, 5-FU 2400 mg/m2 over 46 - 48 hours, bevacizumab 5 mg/kg), intravenously, every 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Leucovorin
2005
Completed Phase 4
~5730
Fluorouracil
2014
Completed Phase 3
~11540
Hydroxychloroquine
2017
Completed Phase 4
~5360
Irinotecan
2017
Completed Phase 4
~2680
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
485,025 Total Patients Enrolled
Eric Chen, MDPrincipal InvestigatorPrincess Margaret Cancer Centre
2 Previous Clinical Trials
66 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment in the last 4-6 weeks or still have side effects.I have never had a retinal disorder.My condition is identified as high DTP-signature for HCQ treatment.I am not pregnant.My brain metastases are stable, and I haven't taken steroids or anticonvulsants for 3 months.I am not pregnant or nursing.I have not had major surgery in the last 28 days, except for a venous access device placement.I don't have conditions that would make taking pills difficult.I have no other cancers, or any I had were cured over 3 years ago, except for certain skin cancers or in situ carcinomas.My colorectal cancer cannot be removed with surgery.My colorectal cancer is not caused by a high level of genetic instability.I haven't had any drug treatments for cancer that has spread.I am fully active or can carry out light work.I do not have a history of G6PD deficiency.My blood, liver, and kidney functions are all within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: High DTP-signature
- Group 2: Low DTP-signature
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experimental program currently available to participants?
"According to clinicaltrials.gov, this trial has ceased recruitment and is no longer accepting new patients. The study was initially posted on April 24th 2023 with the last update occurring on that same date. Fortunately for those hoping to join a medical experiment, there are currently 911 other trials actively recruiting candidates at present."
Answered by AI
How hazardous is exposure to a High DTP-signature?
"Our team at Power assigned High DTP-signature a safety rating of 2, which reflects the fact that there is evidence to suggest it's safe but no proof yet backing its efficacy."
Answered by AI
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