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Hyperthermic Intraperitoneal Oxaliplatin for Peritoneal Malignancies

NCT00625092 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-11-29

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated and nonheated chemotherapy drugs after surgery may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of hyperthermic intraperitoneal oxaliplatin followed by intraperitoneal leucovorin and fluorouracil in treating patients with peritoneal cancer.

Conditions

  • Peritoneal Cavity Cancer

Interventions

DRUG

fluorouracil

Post-operative day 1 and day 2, 600mg/m\^2 intraperitoneal (IP) held for 23 hours

DRUG

leucovorin calcium

Day 0 200 mg/m\^2 intraperitoneal held for 2 hours

DRUG

oxaliplatin

Day 0 hyperthermic intraperitoneal oxaliplatin held for 30 minutes - assigned dose level: Levels 1 through 7 - 300 to 600 mg/m\^2

PROCEDURE

cytoreductive surgery

Day 0 Cytoreductive surgery is a systematic attempt to remove all or nearly all peritoneal nodules.

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Todd M. Tuttle, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-01-31
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00625092 on ClinicalTrials.gov