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

Primary Purpose

Lung Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
doxorubicin hydrochloride
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center
  • Arthur G. James Cancer Hospital - Ohio State University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2000
Last Updated
June 18, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004930
Brief Title
Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases
Official Title
Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Metastatic Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naiyer Rizvi, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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

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