Lung Cancer Clinical Trial
Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
Summary
RATIONALE: Drugs used in chemotherapy, such as epothilone D, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well epothilone D works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy.
Full Description
OBJECTIVES:
Primary
Determine the antitumor activity of epothilone D, in terms of confirmed objective response rate, in patients with stage IIIB or IV non-small cell lung cancer who failed prior initial platinum-containing chemotherapy.
Secondary
Determine the safety of this drug in these patients.
Determine the response duration in patients who achieve complete response or partial response, time to tumor progression, and survival in patients treated with this drug.
Compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment.
Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients.
OUTLINE: This is a multicenter, open-label study.
Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 33-85 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Stage IIIB* or IV disease NOTE: *Due to malignant pleural effusion or supraclavicular lymph node involvement only
Previously treated with maximally feasible surgical resection and/or radiotherapy for initial disease
Failed 1 prior platinum-containing chemotherapy regimen for advanced or metastatic disease due to disease progression or treatment toxicity
At least 1 site of unidimensionally measurable disease by physical exam or radiography
No known CNS metastases or leptomeningeal metastases requiring corticosteroids
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
ECOG 0-1
Life expectancy
More than 3 months
Hematopoietic
Absolute neutrophil count ≥ 1,500/mm^3
Hemoglobin ≥ 8 g/dL
Platelet count ≥ 75,000/mm^3
Hepatic
AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with hepatic metastases)
Alkaline phosphatase ≤ 5 times ULN
Bilirubin ≤ 1.8 mg/dL
Renal
Creatinine ≤ 2.0 mg/dL
Cardiovascular
No New York Heart Association class III or IV congestive heart failure
No personal or family history of congenital long QT syndrome
No QTc interval > 450 msec (males) or > 470 msec (females) by ECG
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No preexisting neuropathy ≥ grade 2
No other malignancy within the past 5 years except for the following:
Cured basal cell skin cancer
Carcinoma in situ of the cervix or urinary bladder
Stage T1 or T2 prostate cancer with prostate-specific antigen < 2 ng/mL
No hypersensitivity reaction ≥ grade 3 to prior Cremophor-containing therapy
No infection requiring parenteral or oral anti-infective therapy
No weight loss of ≥ 10% within the past 3 months
No altered mental status or psychiatric illness that would preclude giving informed consent
No other medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
No concurrent granulocyte-macrophage colony-stimulating factor (sargramostim [GM-CSF])
No concurrent routine prophylactic granulocyte colony-stimulating factor (filgrastim [G-CSF])
Chemotherapy
See Disease Characteristics
At least 3 weeks since prior chemotherapy and recovered
Endocrine therapy
See Disease Characteristics
Radiotherapy
See Disease Characteristics
At least 3 weeks since prior radiotherapy and recovered
Surgery
See Disease Characteristics
At least 3 weeks since prior surgery and recovered
Other
Prior adjuvant or neoadjuvant therapy allowed
Prior radiosensitizers allowed
At least 2 weeks since prior gefitinib
More than 3 weeks since prior investigational agents (therapeutic or diagnostic)
No other concurrent investigational agents
No other concurrent anticancer treatment
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There is 1 Location for this study
New York New York, 10021, United States
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