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Clinical Trials (PDQ®)

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)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Hyperthermia Therapy Plus Chemotherapy in Treating Patients With Cancer of the Stomach or Pancreas

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosed18 and overNCINCI-96-C-0092

Objectives

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.

Entry Criteria

Disease Characteristics:


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


Prior/Concurrent Therapy:


Not specified


Patient Characteristics:


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


Expected Enrollment

The accrual goal is 60 patients over 4 years.

Outline

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

David Bartlett, MD, Protocol chair
Ph: 412-647-3600

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.

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