Study of Hydroxychloroquine With FOLFIRI and Bevacizumab in DTP-high Metastatic Colorectal Cancer

Sponsor
University Health Network, Toronto
Study ID
NCT05843188
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hydroxychloroquine — DRUG
    Anti-Inflammatory - antimalarial - aminoquinolines
  • Irinotecan — DRUG
    Antineoplastic agent
  • Leucovorin — DRUG
    Folic acid derivative
  • Fluorouracil — DRUG
    Antineoplastic agent
  • Bevacizumab — DRUG
    Antineoplastic agent

Study Details

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.

Key Dates

Start date
Aug 9, 2023
Status verified
Dec 2025
Primary completion
Apr 24, 2026
Completion
Oct 24, 2026

Study Design

Enrollment
155 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High DTP-signature
    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
  • Active Comparator: Low DTP-signature
    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

Primary Outcome Measure

Overall response rate [ Time Frame: Start of study treatment to end of study, up to 48 months. ]

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