Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them in different ways may kill more tumor cells. It is not yet known whether surgery followed by chemotherapy is more effective with or without continuous hyperthermic peritoneal perfusion in treating peritoneal carcinomatosis. PURPOSE: This randomized phase III trial is studying chemotherapy and continuous hyperthermic peritoneal perfusion after surgery to see how well they work compared to chemotherapy alone after surgery in treating patients with peritoneal carcinomatosis from gastrointestinal cancer.


Study summary:

OBJECTIVES: - Compare time to intraperitoneal tumor progression after laparotomy and tumor debulking with vs without continuous hyperthermic peritoneal perfusion in patients with peritoneal carcinomatosis from low-grade gastrointestinal adenocarcinoma. - Compare the progression-free and overall survival of patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. - Compare the patterns of failure in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to prior systemic chemotherapy (yes vs no), prior debulking surgery (yes vs no), and ability to debulk tumor (optimal vs sub-optimal debulking). Patients undergo cytoreductive surgery and at the end of the debulking procedure are randomized to 1 of 2 treatment arms. - Arm I: Patients receive continuous hyperthermic peritoneal perfusion (CHPP) with cisplatin over 90 minutes. Patients have a peritoneal dialysis catheter inserted at the end of the procedure in order to receive paclitaxel and fluorouracil postoperatively (once between days 7 and 12). - Arm II: Patients receive no CHPP or postoperative intraperitoneal chemotherapy. Approximately 4-6 weeks after surgery, all patients receive systemic chemotherapy with oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours on days 1, 2, 15, and 16. Patients also receive fluorouracil IV over 15-30 minutes followed by fluorouracil IV continuously over 22 hours beginning on days 1, 2, 15, and 16. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline; 6 weeks postoperatively; after every other course of systemic chemotherapy; and then every 3 months for 2 years, every 4 months for 2 years, and then every 6 months thereafter. Patients are followed every 3 months for 1 year, every 4 months for 2 years, and then every 6 months until 5 years from treatment date (surgery) or evidence of intraperitoneal tumor progression. PROJECTED ACCRUAL: A total of 82 patients (41 per treatment arm) will be accrued for this study within 48 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed peritoneal carcinomatosis from low-grade mucinous adenocarcinoma of the gastrointestinal tract - No imageable disease outside of the peritoneal cavity by radiological workup - Presence of abnormalities consistent with disease that can be debulked to a residual size of less than 1 cm in diameter per tumor deposit, as shown on radiologic workup or prior abdominal exploration PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 16 weeks Hematopoietic - Absolute neutrophil count > 1,500/mm^3 - Platelet count ≥ 75,000/mm^3 Hepatic - Bilirubin < 3 times upper limit of normal (ULN) - AST and ALT ≤ 5 times ULN Renal - Creatinine ≤ 1.5 mg/dL OR - Creatinine clearance > 60 mL/min Cardiovascular - No significant irreversible ischemia on a stress thallium study* OR - Ejection fraction ≥ 40%* NOTE: *Only for patients at increased risk for coronary artery disease or cardiac dysfunction Pulmonary - FEV_1 ≥ 1.2 liters* OR - Maximum voluntary ventilation ≥ 50% of expected* NOTE: *Only for patients with shortness of breath with minimal exertion or for those who are at increased risk for pulmonary disease Other - Not pregnant or nursing - Fertile patients must use effective contraception - Weight ≥ 66 pounds (30 kg) - No other concurrent medical problems that would place patient at an unacceptable risk for a major surgical procedure - No grade 3 or greater neurological toxicity PRIOR CONCURRENT THERAPY: Biologic therapy - At least 30 days since prior immunotherapy and recovered Chemotherapy - At least 30 days since prior chemotherapy and recovered - No prior intraperitoneal chemotherapy failure - No more than 1 prior systemic chemotherapy regimen Endocrine therapy - Not specified Radiotherapy - At least 30 days since prior radiotherapy and recovered Surgery - See Disease Characteristics - No more than 1 prior operative procedure to debulk disease Other - No prior continuous hyperthermic peritoneal perfusion


NCT ID:

NCT00056108


Primary Contact:

Study Chair
James F. Pingpank, MD
NCI - Surgery Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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