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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024271
First received: September 13, 2001
Last updated: January 3, 2014
Last verified: January 2004
  Purpose

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024271

Locations
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
Investigators
Study Chair: Robert N. Taub, MD, PhD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00024271     History of Changes
Other Study ID Numbers: CDR0000068907, CPMC-IRB-13799, NCI-G01-2015
Study First Received: September 13, 2001
Last Updated: January 3, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Mitomycins
Mitomycin
Doxorubicin
Gemcitabine
Cisplatin
Interferons
Interferon-gamma
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 21, 2014