Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004930

Purpose

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.

Condition	Intervention	Phase
Lung Cancer Metastatic Cancer	Drug: doxorubicin hydrochloride	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 1999

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004930

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Naiyer Rizvi, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00004930 History of Changes
Other Study ID Numbers:	CDR0000067614, MSKCC-99049, BMI-98-DOX-001, NCI-G00-1696
Study First Received:	March 7, 2000
Last Updated:	July 23, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent non-small cell lung cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
stage IIIB non-small cell lung cancer

stage IV non-small cell lung cancer
lung metastases
bronchoalveolar cell lung cancer

Additional relevant MeSH terms:

Lung Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases

Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012