Know Cancer

forgot password

Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs

Phase 1
18 Years
Not Enrolling
Lung Cancer, Metastatic Cancer

Thank you

Trial Information

Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs


- 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

- 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


- 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



- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified


- WBC at least 4,000/mm^3

- Platelet count at least 160,000/mm^3

- Hemoglobin at least 9 g/dL


- Bilirubin no greater than 1.0 mg/dL

- AST/ALT less than 1.5 times upper limit of normal


- Creatinine no greater than 1.2 mg/dL OR

- Creatinine clearance at least 50 mL/min


- LVEF normal by MUGA scan or echocardiography

- No unstable angina

- No congestive heart failure

- No symptomatic arrhythmias


- 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


- 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


Biologic therapy:

- Not specified


- 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


- 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


- See Disease Characteristics

- No prior pneumonectomy


- No daily or as necessary respiratory drugs via inhaler or nebulizer

- No other concurrent experimental drugs

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Naiyer Rizvi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




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



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210