Phase II Study of FR901228 in Patients With Refractory or Progressive Small Cell or Non-Small Cell Lung Cancer
Inclusion Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Histologically or cytologically confirmed primary extensive
stage small cell or unresectable non-small cell lung cancer Must have received or refused
prior platinum-based chemotherapy and exhibited refractory or progressive disease Tumor
must be accessible to biopsy by bronchoscopic or percutaneous fine needle aspiration
technique Measurable disease outside of irradiated field or documented progression since
irradiation Extrathoracic metastases allowed No active intracranial or leptomeningeal
metastases Prior surgical resection or radiotherapy for intracranial metastatic disease
allowed if: No evidence of active disease on 2 MRI scans AND No requirement for
anticonvulsant medications or steroids to control residual symptoms --Prior/Concurrent
Therapy-- Biologic therapy: At least 30 days since prior biologic therapy and recovered
Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy,
including nitrosoureas or mitomycin, and recovered No prior FR901228 No prior doxorubicin
of total dose greater than 450 mg/m2 Endocrine therapy: Not specified Radiotherapy: See
Disease Characteristics At least 30 days since prior radiotherapy and recovered At least 4
weeks since prior radiotherapy to the lung or mediastinum Surgery: See Disease
Characteristics --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2
Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3
Absolute neutrophil count at least 1,500/mm3 Hepatic: PT/PTT normal Bilirubin no greater
than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60
mL/min Cardiovascular: Ejection fraction greater than 40% No unstable angina, congestive
heart failure, or uncontrolled cardiac dysrhythmia No deep vein thrombosis requiring
anticoagulation Pulmonary: No pulmonary embolism within past 6 months FEV1 and DLCO
greater than 30% predicted pCO2 less than 50 mm Hg on room air pO2 greater than 60 mm Hg
on room air Other: HIV negative No active infections Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception during and for 6 months
after study
