Clinical trial NCT00227565 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: carboplatin, pemetrexed disodium
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed small cell lung cancer

               -  Previously untreated disease

               -  No mixed histology

          -  Extensive-stage disease

               -  Clinically significant effusions (e.g., symptomatic pleural effusion) must be
                  drained prior to treatment

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques OR ≥ 10 mm by spiral CT scan

          -  No symptomatic, untreated, or uncontrolled CNS metastases

               -  CNS metastases previously treated with whole-brain radiotherapy allowed

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  At least 12 weeks

        Hematopoietic

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

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9.0 g/dL

        Hepatic

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR

          -  Direct bilirubin normal

          -  ALT and AST ≤ 3 times ULN (5 times ULN if there is liver involvement)

        Renal

          -  Creatinine clearance ≥ 45 mL/min

        Cardiovascular

          -  No angina pectoris

          -  No congestive heart failure within the past 3 months, unless ejection fraction > 40%

          -  No cardiac arrhythmia

          -  No myocardial infarction within the past 3 months

          -  No hypertension, including labile hypertension

        Pulmonary

          -  No interstitial pneumonia

          -  No extensive and symptomatic interstitial fibrosis of the lung

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No history of poor compliance with antihypertensive medication

          -  Able to take folic acid, cyanocobalamin (vitamin B_12) supplementation, or
             dexamethasone

          -  No uncontrolled diabetes

          -  No serious condition that would preclude study participation

          -  No clinically significant infection

          -  No significant traumatic injury

          -  No other malignancy within the past 5 years except carcinoma in situ of the cervix or
             nonmelanoma skin cancer

               -  Low-grade (Gleason score ≤ 6), localized prostate cancer allowed even if
                  diagnosed < 5 years prior to study entry

          -  No seizure disorder

          -  No other severe and/or uncontrolled medical condition

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent immunotherapy

          -  No concurrent immunomodulating agents

        Chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  No concurrent hormonal therapy

        Radiotherapy

          -  See Disease Characteristics

          -  Prior palliative radiotherapy allowed

               -  No prior palliative radiotherapy to the chest except for ≤ 3 fractions for
                  superior vena cava syndrome

          -  No concurrent radiotherapy

        Surgery

          -  More than 4 weeks since prior major surgery* (i.e., laparotomy) or open biopsy

          -  More than 2 weeks since prior minor surgery* NOTE: *Insertion of a vascular access
             device is not considered major or minor surgery

        Other

          -  More than 4 weeks since prior investigational therapy

          -  No concurrent Hypericum perforatum (St. John's wort)

          -  No concurrent inducers or inhibitors of CYP3A4

          -  No concurrent medications that are metabolized by CYP3A4

          -  No aspirin dose ≥ 1.3 grams per day for ≥ 10 days prior to and after study treatment

          -  No other concurrent cytostatic or cytotoxic agents