NCT04158349

Intraperitoneal Oxaliplatin in Combo w IV mFOLFIRI for Peritoneal Carcinomatosis From Colorectal & Appendiceal Cancer

Phase I Trial of Intraperitoneal Oxaliplatin in Combination With Intravenous mFOLFIRI for Peritoneal Carcinomatosis From Colorectal and Appendiceal Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multi-center, open-label phase I trial designed to determine the maximun tolerated dose of IP oxaliplatin when given in combination with mFOLFIRI.

Detailed description

This study is a prospective, multi-center, open-label phase I trial designed to determine the MTD of IP oxaliplatin when given in combination with mFOLFIRI. This will be conducted according to a traditional 3+3 dose-escalation schedule and halted once MTD is established. After consent and once deemed eligible for trial participation, patients will receive four cycles of study therapy. During therapy, patients will be monitored for dose-limiting toxicities and adverse events. After completion of all four cycles patients will be followed until resolution of any ongoing study treatment-related adverse events, initiation of alternative treatment, and survival. Study drug treatment will be administered on day one of a 14-day cycle and the DLT evaluation period will be defined as the first three cycles of combination treatment (from cycle one day one to the last day of cycle three). The severity of AEs will be graded according to the NCI-CTCAE version 5.0 A standard 3+3 dose escalation design will be used to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) while ensuring the safety and tolerability of the treatment. The study will test three dose levels of oxaliplatin. Dose Level 2 105 mg/m2 IP every 2 weeks Subjects will be accrued in cohorts of 3 to 6 subjects per dose level starting at Dose Level 0 (85 mg/m2). Escalation will continue until DLT stopping rules are met or the highest dose level is reached.

Conditions

• Colorectal Cancer
• Appendiceal Cancer
• Peritoneal Carcinoma

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Subjects will be accrued in cohorts of 3 to 6 subjects per dose level starting at Dose Level 0 (85 mg/m2). Escalation will continue as described in the protocol until DLT stopping rules are met or the highest dose level is reached.
DRUG	mFOLFIRI	mFOLFIRI is a standardized chemotherapy regimen utilizing 5-fluorouracil, leucovorin, and irinotecan administered on day one of a 14-day cycle. 5-Fluorouracil, leucovorin, and irinotecan should be prepared and administered per the package insert and local institutional guidelines.

Timeline

• Start date: 2021-03-22
• Primary completion: 2021-05-14
• Completion: 2021-05-14
• First posted: 2019-11-08
• Last updated: 2021-09-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study