Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs
Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs
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.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Undersøgelsestype
Fase
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Maryland
-
Bethesda, Maryland, Forenede Stater, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer efter histologisk type
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Adenom
- Neoplasmer, mesotheliale
- Pleurale neoplasmer
- Lungeneoplasmer
- Mesotheliom
- Mesotheliom, ondartet
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Antibiotika, antineoplastisk
- Doxorubicin
- Liposomal doxorubicin
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 000088 (FSRG #1 IRB)
- 00-C-0088
- CDR0000067718
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