Phase II Study of Continuous Hyperthermic Peritoneal Perfusion with CDDP/MITO Administered as Neoadjuvant and Intraoperative Adjuvant Therapy for High-Risk Gastric and Pancreatic Cancers (Summary Last Modified 06/98)
Hyperthermia Therapy Plus Chemotherapy in Treating Patients With Cancer of the Stomach or Pancreas
Basic Trial Information
|Phase II||Treatment||Closed||18 and over||NCI||NCI-96-C-0092|
I. Determine time to recurrence, pattern of recurrence, and survival in patients with resectable, locally advanced adenocarcinoma of the stomach or pancreas treated with neoadjuvant and intraoperative adjuvant continuous hyperthermic peritoneal perfusion (CHPP) with cisplatin/mitomycin (CDDP/MITO). II. Determine the feasibility of administering this regimen within the context of major surgical resection, and examine the rate of operative complications associated with intraoperative adjuvant CHPP. III. Assess the toxicity of CHPP with CDDP/MITO.
Histologically confirmed or high clinical suspicion of gastric or pancreatic adenocarcinoma that is locally advanced but considered completely resectable based on preoperative imaging or staging laparoscopy Minimal discontiguous spread allowed if judged to be completely resectable T3-4 N1-2 M0-1 gastric cancer Extensive pancreatic or liver involvement by an invasive primary tumor may be deemed unresectable No extensive involvement of the gastroesophageal junction such that peritoneal therapy will not reach the tissue at risk T2-3 N1 M0-1 pancreatic cancer No tumor of favorable histology or pathology, e.g., cystic or papillary tumor, cystadenocarcinoma, or ampullary carcinoma
Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic: WBC at least 3,000 Platelets at least 75,000 Low hemoglobin allowed if willing and able to undergo transfusion Hepatic: Temporary biliary stent to relieve biliary obstruction required if bilirubin greater than 7.0 mg/dL or symptoms of pruritus Elevated liver function tests allowed if consistent with obstructive jaundice secondary to localized pancreatic cancer No obstructive jaundice associated with cholangitis Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 70 mL/min Cardiovascular: No increased risk of cardiac disease or adequate cardiac evaluation required (e.g., if over age 65, history of hypertension, family history of coronary artery disease) No significant reversible ischemia by stress thallium study Ejection fraction at least 40% Pulmonary: No increased risk of pulmonary disease or adequate pulmonary function tests (e.g., for chronic smokers) FEV1 at least 1.2 liters Maximum voluntary ventilation at least 50% of expected Other: HIV negative No concomitant medical problem that increases the risk of major surgery No pregnant or nursing women Negative pregnancy test required of fertile women
The accrual goal is 60 patients over 4 years.
All patients undergo preoperative laparoscopic staging and resectability assessment. Patients who are unable to undergo an intial laparoscopic perfusion will undergo resection procedures. The following acronyms are used: CDDP Cisplatin, NSC-119875 CHPP Continuous Hyperthermic Peritoneal Perfusion MITO Mitomycin, NSC-26980 STS Sodium Thiosulfate Neoadjuvant and Adjuvant Intraoperative Hyperthermic Perfusion with 2-Drug Combination Chemotherapy/Chemosensitization with Renal Protection plus Surgery. CHPP; with CDDP/MITO; with STS; plus maximum tumor debulking.
Trial Contact Information
Trial Lead Organizations
NCI - Center for Cancer Research
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.