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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004930 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have primary lung cancer or lung metastases.
Condition | Intervention | Phase |
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Lung Cancer Metastatic Cancer |
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: | July 1999 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive inhaled doxorubicin every 3 weeks. Treatment continues for a maximum of 3 courses in the absence of unacceptable toxicity or disease progression. Patients may reenter at a higher dose level after a 3-month waiting period.
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 6 weeks.
PROJECTED ACCRUAL: A total of 3-36 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:
Histologically confirmed primary lung cancer or cancer metastatic to the lung that is not potentially curable by standard chemotherapy, radiotherapy, or surgery
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
No prior chest (pulmonary or mediastinal) or thoracic spine radiotherapy
Surgery:
Other:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Ohio | |
Arthur G. James Cancer Hospital - Ohio State University | |
Columbus, Ohio, United States, 43210 |
Study Chair: | Naiyer Rizvi, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000067614, MSKCC-99049, BMI-98-DOX-001, NCI-G00-1696 |
Study First Received: | March 7, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004930 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 stage IIIB non-small cell lung cancer |
stage IV non-small cell lung cancer lung metastases bronchoalveolar cell lung cancer |
Thoracic Neoplasms Carcinoma, Small Cell Anti-Bacterial Agents Respiratory Tract Diseases Adenocarcinoma, Bronchiolo-Alveolar Lung Neoplasms |
Lung Diseases Neoplasm Metastasis Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Doxorubicin Recurrence |
Thoracic Neoplasms Respiratory Tract Neoplasms Antineoplastic Agents Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin Neoplasms Neoplastic Processes |
Neoplasms by Site Pathologic Processes Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Neoplasm Metastasis |