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

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: NCT00020124
• Other study ID #: 000088
• Secondary ID: 00-C-0088CDR0000
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2001
• Last updated: March 14, 2012
• Start date: June 2000
• Est. completion date: December 2002

Study information

• Verified date: March 2012
• Source: National Institutes of Health Clinical Center (CC)
• 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. 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.

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.

Other known NCT identifiers

• NCT00004636

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically proven advanced cancer not curable by standard chemotherapy, radiotherapy, or surgery

• Clinical evidence of primary lung or tracheal cancer OR

• Metastatic cancer to the lung

• Extrathoracic metastases eligible if following criteria are met:

• 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• doxorubicin hydrochloride

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,