Clinical trial NCT00334763 (phase 2, status: terminated)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: carboplatin, chemoprotection, paclitaxel
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [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
Reason stopped: 
    principal investigator felt risk to patients was too high.
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

               -  Predominantly squamous cell histology

               -  Cytologic or histologic elements can be established on metastatic tumor aspirates
                  or biopsy

          -  Advanced disease, meeting 1 of the following staging criteria:

               -  Stage IIIB disease with malignant pleural effusion

               -  Stage IV disease

               -  Recurrent, unresectable disease

          -  Measurable or nonmeasurable disease

          -  No extrathoracic only disease

          -  No known CNS metastases by head CT scan with contrast or MRI

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Platelet count > 100,000/mm^3

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

          -  Bilirubin < 1.5 mg/dL

          -  Transaminases < 5 times upper limit of normal (ULN)

          -  Creatinine clearance ≥ 45 mL/min

          -  Urine protein:creatinine ratio ≤ 1.0 by spot urinalysis

          -  INR < 1.5 ULN

          -  PTT normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients use effective contraception

          -  No serious nonhealing wound, ulcer, or bone fracture

          -  No ongoing or active infection

          -  No ongoing fever

          -  No myocardial infarction within the past 6 months

          -  No stroke within the past 6 months

          -  No history of hypertension unless well-controlled (i.e., blood pressure < 150/100 mmHg
             on a stable regimen of antihypertensive therapy)

          -  No New York Heart Association grade III or IV congestive heart failure

          -  No serious cardiac arrhythmia requiring medication

          -  No unstable angina pectoris

          -  No peripheral vascular disease ≥ grade 2

          -  No other clinically significant cardiovascular disease

          -  No abdominal fistula

          -  No gastrointestinal perforation

          -  No intra-abdominal abscess within the past 6 months

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

          -  No other malignancy curatively treated within the past 5 years

          -  No history of thrombotic or hemorrhagic disorders

          -  No gross hemoptysis (i.e., red blood ≥ ½ teaspoon) within the past 3 months

          -  No bleeding requiring intervention or ≥ grade 2

        PRIOR CONCURRENT THERAPY:

          -  Recovered from prior therapy

          -  No prior systemic chemotherapy for metastatic NSCLC

          -  More than 6 months since prior adjuvant chemotherapy for early stage (i.e., stage
             IB-IIIA) NSCLC

          -  More than 3 weeks since prior immunotherapy, hormonal therapy, or radiotherapy

          -  More than 28 days since prior and no concurrent major surgery

          -  More than 7 days since prior minor surgery, fine-needle aspiration, or core biopsy

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

          -  No concurrent therapeutic anticoagulation

               -  Concurrent prophylactic anticoagulation of venous access device allowed

          -  No concurrent chronic treatment with aspirin (> 325 mg/day) or nonsteroidal
             anti-inflammatory drugs known to inhibit platelet function

          -  No concurrent dipyridamole, ticlopidine, clopidogrel, or cilostazol