Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases
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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 1 |
| 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 |
| Study Start Date: | July 1999 |
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 |
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| 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 | |
| Study Chair: | Naiyer Rizvi, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
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 May 22, 2013