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Mesothelioma Related Clinical Trials:
Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma
- General Info - Purpose - Eligibility - Contacts & Locations - Additional Information
Status: Active
Sponsors and Collaborators: Herbert Irving Comprehensive Cancer Center; National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00024271
Condition: Malignant Mesothelioma
Intervention: Drug: cisplatin; Drug: doxorubicin hydrochloride; Drug: gemcitabine hydrochloride; Drug: mitomycin C; Drug: recombinant interferon gamma; Procedure: chemotherapy; Procedure: conventional surgery; Procedure: hyperthermia treatment; Procedure: interferon therapy; Procedure: intraperitoneal chemotherapy; Procedure: radiation therapy
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.
| Study Type: | Interventional |
| Study Design: | 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 |
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:
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: NCT00024271Locations
| 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
| Study Chair: | Robert N. Taub, MD, PhD | Herbert Irving Comprehensive Cancer Center |
Additional Information:
| Study ID Numbers: | CDR0000068907, CPMC-IRB-13799, NCI-G01-2015 |
| First Received: | September 13, 2001 |
| Last Updated: | November 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00024271 |
| Health Authority: | United States: Federal Government |
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