Clinical trial NCT00156286 (phase 2, status: completed)
Conditions: small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: gleevec
SMILES: CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1
Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed extensive-stage SCLC, which is
             c-kit-positive by immunohistochemistry. Extensive-stage is defined as disease that
             extends beyond one hemithorax and regional lymph nodes (ipsilateral or contralateral
             hilar, mediastinal or supraclavicular lymph nodes), or with cytologically positive
             pleural effusion.

          2. No prior chemotherapy for SCLC. Patients who have started therapy with cisplatin and
             irinotecan, at the dosages mentioned in the protocol, prior to registration can be
             registered on the trial if done so within 21 days after the start of the first cycle
             of chemotherapy. Prior palliative radiation therapy will be allowed as long as
             radiation was completed at least 2 weeks before starting protocol therapy.

          3. At least 18 years of age

          4. At least one uni-dimensionally measurable lesion or an evaluable outside the field of
             any prior radiation therapy.

        5. Adequate organ function

        6. Patients must sign informed consent that details the investigational nature of the study
        according to the institutional and federal guidelines.

        Exclusion Criteria:

          1. Symptomatic or history of untreated brain or leptomeningeal metastases. Treated
             patients should be neurologically stable for 2 weeks after completion of appropriate
             therapy.

          2. Previous or concurrent malignancies, with the exception of adequately treated squamous
             cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or any
             other malignancy treated and in clinical remission for more than 3 years.

          3. Major surgery or radiation therapy within 2 weeks of enrollment.

          4. Peripheral neuropathy of NCI grade greater than 2.

          5. Symptomatic edema from any etiology.

          6. Therapeutic anticoagulation with warfarin. Patients can be eligible if they are
             changed from warfarin to low molecular weight heparin or heparin at least 2 weeks
             prior to starting Gleevec.

          7. Serious concomitant medical illness, including, but not limited to, uncontrolled
             congestive cardiac failure, uncontrolled angina, myocardial infarction and/or stroke
             within 3 months, or HIV infection.

          8. Acute or chronic liver disease (e.g., chronic active hepatitis, cirrhosis).

          9. History of dementia, active psychiatric disorder or any other condition, considered by
             the treating physician to impair the patient's ability to take oral pills on a daily
             basis or comply with the protocol requirements.

         10. Pregnant or lactating females. All pre-menopausal and peri-menopausal women should
             have a negative urine pregnancy test prior to enrollment. All patients, men and women,
             of reproductive potential should agree to use an effective contraceptive method for
             the duration of the trial and for 3 months after discontinuation of study treatment.

         11. Patients should not participate in other investigational agent study while taking part
             in this trial.