- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00020124
Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs
Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin in patients with advanced solid tumors affecting the lungs.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacokinetic profile of inhaled doxorubicin in blood in these patients.
- Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients.
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically proven advanced cancer not curable by standard chemotherapy, radiotherapy, or surgery
- Clinical evidence of primary lung or tracheal cancer OR
- Metastatic cancer to the lung
Extrathoracic metastases eligible if following criteria are met:
- Sites are stable
- Pulmonary sites are primary life-threatening sites
- Evidence that study treatment may benefit the patient
- Measurable or evaluable disease
- No germ cell tumor, leukemia, or lymphoma involving the lungs that is treatable with systemic agents
- No complete atelectasis due to high-grade airway obstruction
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- More than 3 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.0 mg/dL
- AST and ALT less than 1.5 times upper limit of normal
Renal:
- Creatinine no greater than 1.6 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- LVEF at least 40% by MUGA scan or echocardiogram
- No unstable angina, congestive heart failure, or symptomatic arrhythmias
Pulmonary:
- DLCO at least 50% predicted
- FVC and FEV1 at least 50% predicted
- Resting oxygen saturation at least 90%
- Exercise oxygen saturation at least 85%
- Oxygen consumption greater than 50% predicted
- No prior radiation pneumonitis
- No asthma
- No radiation-induced pulmonary damage
Other:
- No hypersensitivity to doxorubicin
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
- HIV negative
- No congenital problems (e.g., cleft palate) or other anomalies that prevent tight fit of a mouthseal
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior biologic therapy and recovered
- No prior trastuzumab (Herceptin)
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy and recovered
- Prior doxorubicin allowed if LVEF at least 40% by MUGA scan or echocardiogram
- No prior mitomycin, bleomycin, or nitrosoureas
- No other concurrent systemic chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- At least 12 months since prior radiotherapy to chest
- No prior radiotherapy to more than 20% of total lung volume
- Prior chest wall or primary breast radiotherapy allowed
- Prior radioactive iodine allowed
- No concurrent thoracic radiotherapy
Surgery:
- See Disease Characteristics
- No prior total pneumonectomy
Other:
- No other concurrent experimental drug
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Lung Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- 000088 (FSRG #1 IRB)
- 00-C-0088
- CDR0000067718
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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