Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases

Summary: 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.

Detailed description: 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.

Eligibility: 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

Relevance to patient case: not relevant