Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs
18 Years
N/A
Both
Lung Cancer, Metastatic Cancer
Trial Information
Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs
OBJECTIVES:
- Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin
administered every 3 weeks in patients with primary lung cancer or cancer metastatic to
the lung.
- Determine the toxic effects and pharmacokinetic profile of this regimen in this patient
population.
- Examine the relationship between pharmacodynamic parameters and toxic effects of this
regimen in these patients.
- Obtain preliminary evidence of therapeutic activity of this regimen in these patients.
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary lung cancer or cancer metastatic to the lung that is
not potentially curable by standard chemotherapy, radiotherapy, or surgery
- Bronchoalveolar cell lung cancer allowed
- Lung metastases from soft tissue sarcoma allowed
- No leukemia or lymphoma
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 160,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic:
- Bilirubin no greater than 1.0 mg/dL
- AST/ALT less than 1.5 times upper limit of normal
Renal:
- Creatinine no greater than 1.2 mg/dL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- LVEF normal by MUGA scan or echocardiography
- No unstable angina
- No congestive heart failure
- No symptomatic arrhythmias
Pulmonary:
- DLCO at least 65% of normal
- FVC at least 50% predicted
- FEV1 at least 50% predicted
- Resting oxygen saturation at least 90%
- Exercise oxygen saturation at least 85%
- No complete atelectasis
- No asthma
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
- No congenital problems (e.g., cleft palate) or other anomalies that would prevent
tight fit of mouth seal
- No other concurrent illness that would preclude study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy and recovered
- No prior bleomycin or nitrosoureas
- No prior mitomycin greater than 25 mg/m^2
- No prior anthracyclines greater than 450 mg/m^2
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- No prior chest (pulmonary or mediastinal) or thoracic spine radiotherapy
- Patients with only chest wall or primary breast radiation are eligible
- No concurrent thoracic irradiation
Surgery:
- See Disease Characteristics
- No prior pneumonectomy
Other:
- No daily or as necessary respiratory drugs via inhaler or nebulizer
- No other concurrent experimental drugs
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Naiyer Rizvi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
99-049
NCT ID:
NCT00004930
Start Date:
July 1999
Completion Date:
February 2004
Related Keywords:
- Lung Cancer
- Metastatic Cancer
- 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
- Lung Neoplasms
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
