Clinical trial NCT00081107 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: epothilone d
SMILES: [H]\C(=C(\C)[C@]1([H])C\C([H])=C(C)/CCC[C@]([H])(C)[C@]([H])(O)[C@@]([H])(C)C(=O)C(C)(C)[C@@]([H])(O)CC(=O)O1)C1=CSC(C)=N1
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