At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 14 enrolled

Drug / intervention

Oxaliplatindrug

Likely dose

Oxaliplatin 25mg/m2from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02833753

NCT02833753Phase 1Completed

Compare CT.gov

Phase I Trial of Intraperitoneal Oxaliplatin in Combination With Intravenous FOLFIRI (5-fluorouracil, Leucovorin and Irinotecan) for Peritoneal Carcinomatosis From Colorectal and Appendiceal Cancer

University of Massachusetts, Worcester·interventional·Posted Jul 14, 2016·Updated May 31, 2022

In Brief

A Phase 1 clinical trial evaluating Oxaliplatin for Colorectal Cancer and 2 related conditions. Completed, enrolled 14 participants across 1 site.

Detailed Summary

This is a Phase I dose escalation study to determine how much chemotherapy can be safely administered into the abdomen while experiencing the fewest possible side effects.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsColorectal Cancer, Appendix Cancer, Peritoneal Carcinomatosis

CountriesUnited States

Collaborators--

Timeline

Phase 1CompletedFinished

2017201820192020202120222023202420252026

Enrollment StartJul 2016

First PostedJul 2016

Primary CompletionFeb 2022

TodayJul 2026

First PostedJul 14, 2016

Enrollment StartJul 1, 2016

Primary CompletionFeb 1, 2022

TodayJul 2, 2026

Enrollment to primary: 5.6 yearsPosted 10.0 years ago

Interventions

Oxaliplatindrug

Intraperitoneal oxaliplatin will be given along with standard chemotherapy FOLFIRI. Level 1: Oxaliplatin 25mg/m2 IP every 2 weeks on day #1 of chemotherapy . Level 2: Oxaliplatin 55mg/m2 IP every 2 weeks on day #1 of chemotherapy Level 3: Oxaliplatin 85mg/m2 IP every 2 weeks on day #1 of chemotherapy Level 4: Oxaliplatin 55 mg/m2 IP every 2 weeks on day #1 of chemotherapy (due to DLTs found)