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Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer Clinical research trials and Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer. Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer  Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer
Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer
For Condition: advanced malignant mesothelioma,localized malignant mesothelioma,recurrent malignant mesothelioma
Status: No longer recruiting
Sponsor(s): Herbert Irving Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertTaub, Study Chair, Columbia Presbyterian Medical Center
Herbert Irving Comprehensive Cancer Center at Columbia University
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: CDR0000068907; NCI-G01-2015,CPMC-IRB-13799
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024271
Other Recurrent Malignant Mesothelioma Studies:
1. Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma
2. Neoadjuvant Pemetrexed Disodium and Cisplatin Followed by Surgery and Radiation Therapy in Treating Patients With Pleural Mesothelioma
3. Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
4. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma
5. Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma
Related Studies:
Other recurrent malignant mesothelioma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer
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