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Trial Title:
Study of Hydroxychloroquine With FOLFIRI and Bevacizumab in DTP-high Metastatic Colorectal Cancer
NCT ID:
NCT05843188
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Leucovorin
Hydroxychloroquine
Bevacizumab
Fluorouracil
Irinotecan
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Hydroxychloroquine
Description:
Anti-Inflammatory - antimalarial - aminoquinolines
Arm group label:
High DTP-signature
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Antineoplastic agent
Arm group label:
High DTP-signature
Arm group label:
Low DTP-signature
Intervention type:
Drug
Intervention name:
Leucovorin
Description:
Folic acid derivative
Arm group label:
High DTP-signature
Arm group label:
Low DTP-signature
Other name:
Folinic acid
Intervention type:
Drug
Intervention name:
Fluorouracil
Description:
Antineoplastic agent
Arm group label:
High DTP-signature
Arm group label:
Low DTP-signature
Other name:
5-FU
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Antineoplastic agent
Arm group label:
High DTP-signature
Arm group label:
Low DTP-signature
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed colorectal cancer, not amenable to curative resection.
- Microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal cancer.
- No prior systemic therapy for metastatic disease.
- Evaluable disease based on RECIST 1.1 criteria.
- Adequate hematological, hepatic and renal functions
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.
- Estimated life expectancy of > 6 months.
- Negative pregnancy test for female patients with child-bearing potential.
- No history of retinal disorder.
- No history of glucose-6-phosphate dehydrogenase deficiency (G6PD) .
- Considered to be DTP-signature high to receive HCQ treatment
Exclusion Criteria:
- Women who are pregnant or nursing.
- Have received radiotherapy, chemotherapy, biological therapy, or investigational
treatment less than four weeks (six weeks for nitrosoureas or mitomycin C) prior to
first dose of FOLFIRI-beva or have not recovered from all acute toxicities from
prior treatments to grade 1 or less, with the exception of alopecia and those deemed
not to affect safety assessment.
- Have concurrent malignancy with exception of malignancy that was treated curatively
and without evidence of recurrence within 3 years of study enrollment, or fully
resected basal or squamous cell skin cancer and any carcinoma in situ which are
considered to be of low risk of recurrence.
- Have had major surgery within 28 days of study enrollment. Placement of a venous
access device within 28 days of starting therapy is allowed.
- Have any medical condition that would impair the administration of oral agents
including significant bowel resection, inflammatory bowel disease or uncontrolled
nausea or vomiting.
- Known central nervous system metastasis. Patients with history of central nervous
system metastases are eligible if they are clinically and radiographically stable
for at least 3 months and not taking steroids or anticonvulsants.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sunnybrook Odette Cancer Centre
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Sheron Perera, Dr.
Phone:
416-480-4757
Email:
sheron.perera@sunnybrook.ca
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Eric Chen, MD
Phone:
416-946-2263
Email:
eric.chen@uhn.ca
Investigator:
Last name:
Eric Chen, MD
Email:
Principal Investigator
Start date:
August 9, 2023
Completion date:
October 24, 2026
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05843188
