Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00024271 |
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 II |
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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University | |
New York, New York, United States, 10032 |
Study Chair: | Robert N. Taub, MD, PhD | Herbert Irving Comprehensive Cancer Center |
Study ID Numbers: | CDR0000068907, CPMC-IRB-13799, NCI-G01-2015 |
Study First Received: | September 13, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00024271 History of Changes |
Health Authority: | United States: Federal Government |
localized malignant mesothelioma advanced malignant mesothelioma recurrent malignant mesothelioma |
Antimetabolites Anti-Infective Agents Immunologic Factors Interferon Type II Interferons Immunosuppressive Agents Antiviral Agents Mitomycins Recurrence Doxorubicin |
Anti-Bacterial Agents Radiation-Sensitizing Agents Cisplatin Mitomycin Mesothelioma Gemcitabine Adenoma Alkylating Agents Neoplasms, Glandular and Epithelial Interferon-gamma, Recombinant |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Interferon Type II Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Therapeutic Uses Mitomycin Gemcitabine Alkylating Agents |
Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Interferons Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Mesothelioma Adenoma Interferon-gamma, Recombinant Neoplasms, Glandular and Epithelial |