Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs

NCT ID: NCT00020124

Last Updated: 2012-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30
• Study Completion Date: 2002-12-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have advanced solid tumors affecting the lungs.

Detailed Description

OBJECTIVES:

• Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin in patients with advanced solid tumors affecting the lungs.
• Determine the toxicity of this regimen in these patients.
• Determine the pharmacokinetic profile of inhaled doxorubicin in blood in these patients.
• Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive inhaled doxorubicin every 3 weeks for up to 3 doses. Patients with stable or responding disease may receive additional doses in the absence of disease progression or unacceptable toxicity.

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 3 weeks and 3 months.

PROJECTED ACCRUAL: Approximately 33 patients will be accrued for this study within 18-24 months.

Conditions

Lung Cancer; Malignant Mesothelioma; Metastatic Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

doxorubicin hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Sites are stable
• Pulmonary sites are primary life-threatening sites
• Evidence that study treatment may benefit the patient
• Measurable or evaluable disease
• No germ cell tumor, leukemia, or lymphoma involving the lungs that is treatable with systemic agents
• No complete atelectasis due to high-grade airway obstruction

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• More than 3 months

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 1.0 mg/dL
• AST and ALT less than 1.5 times upper limit of normal

Renal:

• Creatinine no greater than 1.6 mg/dL OR
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• LVEF at least 40% by MUGA scan or echocardiogram
• No unstable angina, congestive heart failure, or symptomatic arrhythmias

Pulmonary:

• DLCO at least 50% predicted
• FVC and FEV1 at least 50% predicted
• Resting oxygen saturation at least 90%
• Exercise oxygen saturation at least 85%
• Oxygen consumption greater than 50% predicted
• No prior radiation pneumonitis
• No asthma
• No radiation-induced pulmonary damage

Other:

• No hypersensitivity to doxorubicin
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study
• HIV negative
• No congenital problems (e.g., cleft palate) or other anomalies that prevent tight fit of a mouthseal

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior biologic therapy and recovered
• No prior trastuzumab (Herceptin)

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy and recovered
• Prior doxorubicin allowed if LVEF at least 40% by MUGA scan or echocardiogram
• No prior mitomycin, bleomycin, or nitrosoureas
• No other concurrent systemic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered
• At least 12 months since prior radiotherapy to chest
• No prior radiotherapy to more than 20% of total lung volume
• Prior chest wall or primary breast radiotherapy allowed
• Prior radioactive iodine allowed
• No concurrent thoracic radiotherapy

Surgery:

• See Disease Characteristics
• No prior total pneumonectomy

Other:

• No other concurrent experimental drug

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Principal Investigators

David S. Schrump, MD

Role: STUDY_CHAIR

NCI - Surgery Branch

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

00-C-0088

Identifier Type: -

Identifier Source: secondary_id

CDR0000067718

Identifier Type: -

Identifier Source: secondary_id

000088

Identifier Type: -

Identifier Source: org_study_id

NCT00004636

Identifier Type: -

Identifier Source: nct_alias