Intraperitoneal Irinotecan With Concomitant FOLFOX and Bevacizumab

Sponsor
Catharina Ziekenhuis Eindhoven
Study ID
NCT06003998
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
    2 weekly IP irinotecan (max 12 cycles), dose 75 mg flat dose
  • FOLFOX regimen — DRUG
    FOLFOX-4 regimens consist of 85 mg/m2 oxaliplatin plus 200 mg/m2 LV and 5-FU 400 mg/m2 bolus on day 1 followed by 1600 mg/m2 5-FU as a 46-h infusion
  • Bevacizumab — DRUG
    Bevacizumab according to standard of care

Study Details

The rationale of the current study is that the addition of intraperitoneal irinotecan (75 mg) to palliative systemic therapy is feasible and safe, and might result in an increased overall and progression free survival in patients with unresectable colorectal peritoneal metastases. The primary objectives are to explore the overall survival for the addition of intraperitoneal irinotecan (75 mg) to palliative systemic therapy in patients with unresectable colorectal peritoneal metastases. Secondary objectives are to assess the progression-free survival, toxicity profile, patient reported outcomes, costs, tumor response during trial treatment, and the systemic and intraperitoneal pharmacokinetics of irinotecan and SN-38. This is a single-arm, open-label, phase II study and patients will receive intraperitoneal irinotecan (75 mg) in combination with modified FOLFOX4 + bevacizumab.

Key Dates

Start date
Dec 27, 2022
Status verified
Aug 2023
Primary completion
Jan 1, 2025
Completion
Jan 1, 2025

Study Design

Enrollment
85 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intraperitoneal irinotecan 75 mg + mFOLFOX-4 and bevacizumab
    Intraperitoneal irinotecan, 75 mg flat dose + systemic oxaliplatin, 5-Fluorouracil and bevacizumab (mFOLFOX+beva) (dose via standard of care)

Primary Outcome Measure

Overall survival [ Time Frame: 3 year ]

Central Contacts

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