Clinical trial NCT00248482 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: cisplatin, gleevec™, irinotecan
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1, CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=CC=CC=C4N=C13)C2=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed small cell lung cancer (SCLC)

               -  Extensive stage disease, defined by 1 of the following criteria:

                    -  Disease extends beyond one hemithorax and regional lymph nodes

                    -  Cytologically positive pleural effusion

          -  Meets 1 of the following criteria:

               -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion outside the
                  field of any prior radiotherapy

               -  Evaluable disease

          -  No history of untreated or symptomatic brain or leptomeningeal metastases

               -  Prior brain metastases allowed provided patient is neurologically stable for 2
                  weeks after completion of therapy

        PATIENT CHARACTERISTICS:

        Performance status

          -  SWOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 8 g/dL

        Hepatic

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

          -  Meets 1 of the following criteria:

               -  Alkaline phosphatase (AP) normal AND AST and ALT ≤ 2.5 times ULN

               -  AP ≤ 5 times ULN AND AST and ALT normal

          -  No acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis)

        Renal

          -  Creatinine normal OR

          -  Creatinine clearance ≥ 65 mL/min

        Cardiovascular

          -  No uncontrolled congestive heart failure

          -  No uncontrolled angina

          -  No myocardial infarction and/or stroke within the past 3 months

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  No peripheral neuropathy ≥ grade 2

          -  No symptomatic edema from any etiology

          -  No known HIV positivity

          -  No other serious medical illness

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

          -  No history of dementia, active psychiatric disorder, or other condition that would
             preclude study compliance or ability to take oral medication on a daily basis

        PRIOR CONCURRENT THERAPY:

        Chemotherapy

          -  No prior chemotherapy for SCLC

        Endocrine therapy

          -  No concurrent routine systemic corticosteroids

        Radiotherapy

          -  See Disease Characteristics

          -  At least 2 weeks since prior palliative radiotherapy

        Surgery

          -  More than 2 weeks since prior major surgery

        Other

          -  No concurrent therapeutic anticoagulation with warfarin

               -  Concurrent low molecular weight heparin allowed provided regimen was initiated ≥
                  2 weeks prior to study entry

          -  No other concurrent participation in another study of an investigational agent