Lung Cancer
Conditions
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Brief 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.
Detailed 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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Countries
United States