Clinical trial NCT00096486 (phase 1/phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: everolimus, gefitinib
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following
             stage criteria:

               -  Stage IIIB (unresectable, with malignant pleural or pericardial effusion)

               -  Stage IV disease

               -  Recurrent disease

          -  Measurable or evaluable indicator lesions

          -  Progressive disease after receiving ≥ 1 prior chemotherapy regimen that included
             cisplatin or carboplatin and docetaxel

          -  No uncontrolled brain or leptomeningeal metastases

               -  Must not require concurrent glucocorticoids for control of metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Karnofsky 70-100% OR

          -  ECOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  WBC ≥ 3,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9.0 g/dL

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST ≤ 2.5 times ULN

        Renal

          -  Creatinine ≤ 1.5 times ULN OR

          -  Creatinine clearance ≥ 60 mL/min

        Cardiovascular

          -  No congestive heart failure

          -  No New York Heart Association class III or IV heart disease

          -  No unstable angina

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No severe infection

          -  No severe malnutrition

          -  No other serious medical illness

          -  No other malignancy within the past 3 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent biologic therapy

          -  No concurrent immunotherapy

        Chemotherapy

          -  See Disease Characteristics

          -  No prior conventional chemotherapy for metastatic or recurrent NSCLC (phase II only)

          -  At least 4 weeks since prior chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  See Disease Characteristics

          -  No concurrent oral steroids for management of skin toxicity

        Radiotherapy

          -  At least 4 weeks since prior radiotherapy

          -  No concurrent radiotherapy

        Surgery

          -  At least 4 weeks since prior major surgery

          -  No concurrent surgery for an identifiable lesion

        Other

          -  Recovered from all prior therapy

          -  No prior gefitinib, erlotinib, or other epidermal growth factor tyrosine kinase
             inhibitor

          -  No concurrent cytotoxic therapy (e.g., methotrexate for rheumatoid arthritis)

          -  No other concurrent oncolytic agents