Hyperthermic Intraperitoneal Oxaliplatin for Peritoneal Malignancies

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Calcium; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion criteria:

• 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

Exclusion criteria:

• 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.