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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Study Completion Date

2004-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer Metastatic Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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doxorubicin hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No