Hydroxychloroquine + FOLFIRI + Bevacizumab for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a two arm, 2-center, Phase II, study of 5-FU, irinotecan, bevacizumab (FOLFIRI-beva) and hydroxychloroquine (HCQ) in patients with previously untreated metastatic colorectal cancer (mCRC).Up to 155 patients will be screened for DTP-signature and up to 31 evaluable patients who are determined to be DTP-signature high will be treated with FOLFIRI-beva and HCQ.Patients will continue to receive treatments until evidence of disease progression, intolerable side effects, withdrawal of consent or death.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received radiotherapy, chemotherapy, biological therapy, or investigational treatment less than four weeks before the first dose of the trial drugs.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have had recent treatments like chemotherapy or radiotherapy, you must wait at least four weeks before starting the trial.
What safety data is available for the treatment of Hydroxychloroquine + FOLFIRI + Bevacizumab in colorectal cancer?
The safety data for Bevacizumab, when used in combination with chemotherapy for colorectal cancer, indicates that it is generally well-tolerated. Common adverse effects include hypertension, proteinuria, arterial thrombosis, effects on wound healing, bleeding, and gastrointestinal perforation. These side effects are mostly mild to moderate and manageable, though some, like GI perforations and arterial thrombosis, occur less frequently. Bevacizumab-based chemotherapy has been shown to lower risks of dermatological and renal adverse events but increases cardiovascular risks such as hypertension and arrhythmia. Overall, Bevacizumab is considered a suitable adjunct to standard chemotherapy in colorectal cancer treatment.12345
Is the combination of Hydroxychloroquine, FOLFIRI, and Bevacizumab safe for treating colorectal cancer?
Bevacizumab, when used with chemotherapy for colorectal cancer, is generally well-tolerated but can cause side effects like high blood pressure, protein in urine, and rare serious events like bleeding or gastrointestinal issues. The combination with FOLFIRI has shown manageable side effects, with some risk of cardiovascular issues.12345
Is the drug combination of Bevacizumab, Fluorouracil, Hydroxychloroquine, Irinotecan, and Leucovorin promising for colorectal cancer?
What makes the Hydroxychloroquine + FOLFIRI + Bevacizumab treatment unique for colorectal cancer?
This treatment is unique because it combines hydroxychloroquine, which is typically used for conditions like malaria and autoimmune diseases, with a standard chemotherapy regimen (FOLFIRI) and bevacizumab, a drug that inhibits blood vessel growth in tumors. This combination aims to enhance the effectiveness of chemotherapy by potentially disrupting cancer cell survival mechanisms.36789
What data supports the idea that Hydroxychloroquine + FOLFIRI + Bevacizumab for Colorectal Cancer is an effective treatment?
The available research shows that combining Bevacizumab with FOLFIRI (which includes drugs like 5-fluorouracil, leucovorin, and irinotecan) improves outcomes for patients with advanced colorectal cancer. Specifically, it increases the time patients live without the cancer getting worse and overall survival time. Studies have shown that adding Bevacizumab to these chemotherapy regimens significantly improves the response rate and delays tumor progression. However, the research does not specifically mention Hydroxychloroquine in combination with these drugs for colorectal cancer, so its effectiveness in this combination is not directly supported by the data provided.1011121314
What data supports the effectiveness of the drug combination Hydroxychloroquine + FOLFIRI + Bevacizumab for colorectal cancer?
Research shows that Bevacizumab, when combined with FOLFIRI (a chemotherapy regimen including 5-fluorouracil, leucovorin, and irinotecan), significantly improves survival and slows disease progression in patients with metastatic colorectal cancer. This combination has been shown to be more effective than using 5-fluorouracil and leucovorin alone.1011121314
Who Is on the Research Team?
Eric Chen, MD
Principal Investigator
Princess Margaret Cancer Centre
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive FOLFIRI-beva and HCQ until disease progression, intolerable side effects, withdrawal of consent, or death
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Fluorouracil
- Hydroxychloroquine
- Irinotecan
- Leucovorin
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor