Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI MSKCC-99049 BMI-98-DOX-001, NCI-G00-1696, NCT00004930

Objectives

1. 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.
2. Determine the toxic effects and pharmacokinetic profile of this regimen in this patient population.
3. Examine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients.
4. Obtain preliminary evidence of therapeutic activity of this regimen in these patients.

Entry 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

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/m²
• No prior anthracyclines greater than 450 mg/m²
• 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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm³
• Platelet count at least 160,000/mm³
• 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

Expected Enrollment

A total of 3-36 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Naiyer Rizvi, MD, Protocol chair		Ph: 212-639-3204; 800-525-2225

Registry Information
Official Title		Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults with Advanced Solid Tumors Affecting the Lungs
Trial Start Date		1999-07-27
Registered in ClinicalTrials.gov		NCT00004930
Date Submitted to PDQ		2000-01-13
Information Last Verified		2004-04-15
NCI Grant/Contract Number		P30-CA08748

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