Clinical trial NCT00234052 (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
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically* or cytologically* confirmed non-small cell lung cancer

               -  Any histology, except squamous cell carcinoma, allowed

                    -  Mixed tumors will be categorized by the predominant cell type unless small
                       cell elements are present, in which case the patient is ineligible

               -  No histology in close proximity to a major vessel or cavitation NOTE: *Histologic
                  or cytologic elements may be established on metastatic tumor aspirates or biopsy

          -  Meets 1 of the following stage criteria:

               -  Stage IIIB disease (with malignant pleural effusion)

               -  Stage IV disease

               -  Recurrent disease

          -  Measurable or non-measurable disease

          -  No known CNS metastases by CT scan or MRI

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

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

          -  Platelet count > 100,000/mm^3

          -  No history of hemorrhagic disorders

        Hepatic

          -  Bilirubin < 1.5 mg/dL

          -  AST and ALT < 5 times upper limit of normal

          -  INR < 1.5

          -  PTT normal

        Renal

          -  Creatinine clearance ≥ 45 mL/min

          -  Urine protein:creatinine ≤ 1.0 by spot urinalysis

        Cardiovascular

          -  No myocardial infarction within the past 6 months

          -  No New York Heart Association class II-IV congestive heart failure

          -  No unstable angina pectoris

          -  No serious cardiac arrhythmia requiring medication

          -  No stroke within the past 6 months

          -  No peripheral vascular disease ≥ grade 2

          -  No uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg)

               -  Patients with a history of hypertension allowed provided blood pressure is well
                  controlled on a stable regimen of anti-hypertensive therapy

          -  No history of thrombotic disorders

          -  No other clinically significant cardiovascular disease

        Pulmonary

          -  No history of gross hemoptysis, defined as bright red blood of a ½ teaspoon or more

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Must be willing and able to take daily oral folic acid, intermittent vitamin B_12
             injections, and corticosteroid premedication

          -  No ongoing or active infection

          -  No serious, non-healing wound, ulcer, or bone fracture

          -  No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
             the past 6 months

          -  No psychiatric illness or social situation that would preclude study compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  More than 3 weeks since prior immunotherapy

        Chemotherapy

          -  No prior systemic chemotherapy

        Endocrine therapy

          -  More than 3 weeks since prior hormonal therapy

        Radiotherapy

          -  See Disease Characteristics

          -  More than 3 weeks since prior radiotherapy

        Surgery

          -  More than 4 weeks since prior major surgery

          -  More than 1 week since prior minor surgery, fine needle aspiration, or core biopsy

          -  No concurrent major surgery

        Other

          -  Recovered from all prior therapy

          -  More than 4 weeks since prior and no concurrent participation in another experimental
             drug study

          -  No aspirin or other nonsteroidal anti-inflammatory drug (NSAID) 2 days before and 2
             days after each pemetrexed disodium infusion (5 days before and 2 days after each
             pemetrexed disodium infusion for NSAIDs with a long half-life [e.g., naproxen,
             rofecoxib, or celecoxib])

          -  No concurrent therapeutic anticoagulation

               -  Concurrent prophylactic anticoagulation for venous access devices allowed
                  provided requirements for INR and PTT are met

          -  No concurrent administration of any of the following:

               -  Chronic daily treatment with aspirin (> 325 mg per day)

               -  NSAIDs known to inhibit platelet function, including any of the following:

                    -  Dipyridamole

                    -  Ticlopidine

                    -  Clopidogrel

                    -  Cilostazol