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

Condition(s) targeted: Malignant Mesothelioma

Intervention: cisplatin (Drug); doxorubicin hydrochloride (Drug); gemcitabine hydrochloride (Drug); mitomycin C (Drug); recombinant interferon gamma (Drug); chemotherapy (Procedure); conventional surgery (Procedure); hyperthermia treatment (Procedure); interferon therapy (Procedure); intraperitoneal chemotherapy (Procedure); radiation therapy (Procedure)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Official(s) and/or principal investigator(s):
Robert N. Taub, MD, PhD, Study Chair, Affiliation: Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

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.

Official title: Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma

Study design: Treatment

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS: Histologically confirmed malignant mesothelioma Measurable or evaluable disease Ineligible for other high-priority study No CNS metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Karnofsky 60-100% Life expectancy: More than 2 months Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1. 5 times normal Renal: Creatinine clearance at least 45 mL/min BUN less than 1. 5 times normal No significant calcium abnormalities Cardiovascular: No symptomatic cardiovascular disease No New York Heart Association class II, III, or IV heart disease No congestive heart failure No angina pectoris No cardiac arrhythmia No uncontrolled hypertension Other: No significant phosphate, electrolyte, or other metabolic abnormalities (e. g., metabolic acidosis) No uncontrolled psychiatric disorder or neurologic disease No seizure disorder No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or skin cancer No other serious medical or psychiatric illness No uncontrolled serious infection No senility or emotional instability Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 2 prior chemotherapy regimens No more than 1 prior intraperitoneal chemotherapy regimen More than 6 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except for nondisease-related conditions (e. g., insulin for diabetes) Concurrent steroids for antiemesis, premedication, adrenal failure, or septic shock allowed Radiotherapy: No prior abdominal, pelvic, or lower chest radiotherapy Surgery: Prior surgical resection preceding disease recurrence allowed More than 1 week since prior surgery

Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York 10032, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: May 2001
Last updated: November 16, 2007