Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs
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Purpose
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 |
|---|---|---|
|
Lung Cancer Malignant Mesothelioma Metastatic Cancer |
Drug: doxorubicin hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Study Completion Date: | December 2002 |
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.
Eligibility| 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
- 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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00020124 History of Changes |
| Obsolete Identifiers: | NCT00004636 |
| Other Study ID Numbers: | 000088, 00-C-0088, CDR0000067718 |
| Study First Received: | July 11, 2001 |
| Last Updated: | March 14, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
recurrent non-small cell lung cancer extensive stage small cell lung cancer recurrent small cell lung cancer advanced malignant mesothelioma recurrent malignant mesothelioma |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer pulmonary carcinoid tumor lung metastases |
Additional relevant MeSH terms:
|
Lung Neoplasms Mesothelioma Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Adenoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial Neoplastic Processes Pathologic Processes Doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013