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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004930
• Other study ID #: 99-049
• Secondary ID: CDR0000067614BMI
• Status: Completed
• Phase: Phase 1
• First received: March 7, 2000
• Last updated: June 18, 2013
• Start date: July 1999
• Est. completion date: February 2004

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• doxorubicin hydrochloride

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,