Hyperthermic Intraperitoneal Oxaliplatin for Peritoneal Malignancies

NCT00625092 | Completed Phase 1 DMC

• 2 other identifiers: 2005LS0680601M79448
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

peritoneal cavity cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of hyperthermic intraperitoneal oxaliplatin

  30 Days Post Treatment

Secondary Outcomes (3)

• Changes in quality-of-life

  Baseline and at 4, 8, and 12 months

• Overall survival

  1 Year and 5 Years

• Time to Disease Progression

  Monthly

Study Arms (1)

Hyperthermic Treatment

EXPERIMENTAL

Patients receiving combination of hyperthermic intraperitoneal chemotherapy (HIPC) with oxaliplatin plus intraperitoneal 5-Fu and intraperitoneal leucovorin with peritoneal metastases.

Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Procedure: cytoreductive surgery

Interventions

fluorouracil DRUG

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

Also known as: 5-FU

Hyperthermic Treatment

leucovorin calcium DRUG

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

Hyperthermic Treatment

oxaliplatin DRUG

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

Also known as: Eloxatin

Hyperthermic Treatment

cytoreductive surgery PROCEDURE

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

Also known as: conventional surgery

Hyperthermic Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologic proof of peritoneal metastases (includes adenomucinosis)
• Complete tumor resection possible (may include liver metastasis if treatable by resection or radiofrequency ablation)
• Patients may have received previous chemotherapy (except peritoneal) and/or immunotherapy. If previous chemotherapy, at least 4 weeks must have passed since last dose.
• Patients may have received previous radiation therapy, however radiation to the large bowel, small bowel and/or stomach will make the patient ineligible for this study.
• Patients must have a Karnofsky performance score of ≥ 80%.
• Adequate hematologic, renal and hepatic function within 14 days of registration defined as:
• White blood count (WBC) ≥ 3,000
• platelet count ≥ 70,000,
• serum bilirubin ≤ 2.0 mg/dL,
• serum creatinine ≤ 1.5 mg/dL
• Patients must be at least 18 years of age
• Patients must be able to provide informed consent

You may not qualify if:

• Metastatic disease is present outside the peritoneal cavity
• Diagnosis of mesothelioma
• Grade 2 or higher sensory neuropathy at time of study enrollment
• History of allergic reaction to platinum compounds
• Pregnant or lactating women. Pregnancy is a contraindication for receiving therapy, thus where relevant, patients will be required to use effective birth control. The agents used in this study include those which are pregnancy category D - clear evidence of risk in pregnancy. There is no information on the excretion of agents into breast milk therefore patients must refrain from breastfeeding while receiving study therapy.
• Previous peritoneal chemotherapy.
• Patients with uncontrolled concurrent medical problems (i.e. diabetes mellitus) or history of uncontrolled cardiovascular disease (no history of hospitalization for acute myocardial infarction or congestive heart failure (CHF) within 3 months prior to registration).
• Patients have psychiatric or addictive disorders that preclude obtaining informed consent.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin; Cytoreduction Surgical Procedures

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Surgical Procedures, Operative

Study Officials

• Todd M. Tuttle, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: February 28, 2008
• Study Start: October 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: September 1, 2011
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (1)