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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: September 13, 2001
Last updated: January 3, 2014
Last verified: January 2004

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.

Condition Intervention Phase
Malignant Mesothelioma Biological: recombinant interferon gamma Drug: cisplatin Drug: doxorubicin hydrochloride Drug: gemcitabine hydrochloride Drug: mitomycin C Procedure: conventional surgery Procedure: hyperthermia treatment Radiation: radiation therapy Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2001
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignant mesothelioma
  • Measurable or evaluable disease
  • Ineligible for other high-priority study
  • No CNS metastases



  • Over 18

Performance status:

  • SWOG 0-2
  • Karnofsky 60-100%

Life expectancy:

  • More than 2 months


  • WBC greater than 3,000/mm3
  • Platelet count greater than 100,000/mm3


  • Bilirubin less than 1.5 times normal


  • Creatinine clearance at least 45 mL/min
  • BUN less than 1.5 times normal
  • No significant calcium abnormalities


  • 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


  • 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


Biologic therapy:

  • Not specified


  • 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


  • No prior abdominal, pelvic, or lower chest radiotherapy


  • Prior surgical resection preceding disease recurrence allowed
  • More than 1 week since prior surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00024271

United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Robert N. Taub, MD, PhD Herbert Irving Comprehensive Cancer Center
  More Information Identifier: NCT00024271     History of Changes
Other Study ID Numbers: CDR0000068907
Study First Received: September 13, 2001
Last Updated: January 3, 2014

Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Liposomal doxorubicin
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic processed this record on September 21, 2017