NCT00004930

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 1999

Typical duration for phase_1 lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

4.6 years

First QC Date

March 7, 2000

Last Update Submit

June 18, 2013

Conditions

Lung CancerMetastatic Cancer

Keywords

recurrent non-small cell lung cancerextensive stage small cell lung cancerrecurrent small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerlung metastasesbronchoalveolar cell lung cancer

Interventions

doxorubicin hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsNeoplasm MetastasisCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaAdenocarcinoma, Bronchiolo-Alveolar

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinoma of LungAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Naiyer Rizvi, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2000

First Posted

January 27, 2003

Study Start

July 1, 1999

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(2)