Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer

Phase 2

• Conditions: Malignant Mesothelioma

• Registration Number: NCT00024271
• Lead Sponsor: Herbert Irving Comprehensive Cancer Center

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs directly into the tumor after surgery and combining them with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy, and radiation therapy in treating patients who have peritoneal cancer.

Detailed Description

OBJECTIVES:

* Determine the response rate, duration of response, and duration of survival of patients with peritoneal mesothelioma treated with surgery, intraperitoneal chemotherapy, and whole abdominal radiotherapy.

* Determine the toxicity of this regimen in these patients.

OUTLINE: Patients undergo initial surgery, including total omentectomy and excision of gross disease. Approximately 3-4 weeks after surgery, patients receive intraperitoneal (IP) chemotherapy consisting of doxorubicin IP over 2 hours once weekly on weeks 1, 4, 7, and 10 and cisplatin IP and gemcitabine IP once weekly on weeks 2, 5, 8, and 11. Patients also receive interferon gamma IP once weekly on weeks 13-16.

At approximately week 18-20, patients undergo second-look surgery. Patients with no gross disease receive hyperthermia mitomycin IP and cisplatin IP over 90 minutes.

Approximately 2-4 weeks after second-look surgery, patients undergo radiotherapy 5 days a week for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2001-09-13
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2004-01
• Last Update Submitted: 2014-01-03
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Herbert Irving Comprehensive Cancer Center at Columbia University; 🇺🇸 New York, New York, United States