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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020124 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have advanced solid tumors affecting the lungs.
Condition | Intervention | Phase |
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Lung Cancer Malignant Mesothelioma Metastatic Cancer Thymoma and Thymic Carcinoma |
Drug: doxorubicin hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive inhaled doxorubicin every 3 weeks for up to 3 doses. Patients with stable or responding disease may receive additional doses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 3 weeks and 3 months.
PROJECTED ACCRUAL: Approximately 33 patients will be accrued for this study within 18-24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven advanced cancer not curable by standard chemotherapy, radiotherapy, or surgery
Extrathoracic metastases eligible if following criteria are met:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | David S. Schrump, MD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000067718, NCI-00-C-0088 |
Study First Received: | July 11, 2001 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00020124 History of Changes |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer extensive stage small cell lung cancer recurrent small cell lung cancer advanced malignant mesothelioma recurrent malignant mesothelioma invasive thymoma and thymic carcinoma |
recurrent thymoma and thymic carcinoma stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer pulmonary carcinoid tumor lung metastases |
Thoracic Neoplasms Doxorubicin Recurrence Carcinoma Carcinoma, Small Cell Anti-Bacterial Agents Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Thymoma Thymus Neoplasms Neoplasm Metastasis Non-small Cell Lung Cancer Mesothelioma Carcinoid Tumor Adenoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Neoplasms, Mesothelial Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin Carcinoma Neoplastic Processes Neoplasms Pathologic Processes |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Thymoma Thymus Neoplasms Neoplasm Metastasis Mesothelioma Adenoma Neoplasms, Complex and Mixed Neoplasms, Glandular and Epithelial |