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

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ClinicalTrials.gov Identifier: NCT00024271
Recruitment Status : Unknown
Verified January 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 6, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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 or disease Intervention/treatment 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

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma
Study Start Date : May 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00024271


Locations
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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)
Investigators
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Study Chair: Robert N. Taub, MD, PhD Herbert Irving Comprehensive Cancer Center
More Information
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ClinicalTrials.gov Identifier: NCT00024271     History of Changes
Other Study ID Numbers: CDR0000068907
CPMC-IRB-13799
NCI-G01-2015
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 2004
Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Gemcitabine
Interferons
Interferon-gamma
Doxorubicin
Liposomal doxorubicin
Mitomycins
Mitomycin
Antineoplastic Agents
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Alkylating Agents
Nucleic Acid Synthesis Inhibitors