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

Primary Purpose

Malignant Mesothelioma

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon gamma
cisplatin
doxorubicin hydrochloride
gemcitabine hydrochloride
mitomycin C
conventional surgery
hyperthermia treatment
radiation therapy
Sponsored by
Herbert Irving Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Mesothelioma focused on measuring localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herbert Irving Comprehensive Cancer Center at Columbia University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
January 3, 2014
Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00024271
Brief Title
Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer
Official Title
Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2004
Overall Recruitment Status
Unknown status
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Mesothelioma
Keywords
localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon gamma
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
mitomycin C
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
hyperthermia treatment
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert N. Taub, MD, PhD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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

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