Clinical trial NCT00352690 (phase 2, status: terminated)
Conditions: carcinoma, non-small-cell lung
ICD codes: D02.20, D02.21, D02.22
Drugs: paclitaxel poliglumex, carboplatin
SMILES: [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, N[C@@H](CCCNC(N)=N)C(O)=O
Reason stopped: 
    safety of patients
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically documented NSCLC, including squamous cell carcinoma,
             adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma
             (including giant and clear cell carcinomas).

          -  Eligible Disease Stages: Inoperable IIIA and Selected IIIB

          -  Local radiation oncologist must approve patient eligibility prior to entry on study.

          -  Patients must have measurable disease.

          -  Prior Therapy:

               -  ≥ 2 weeks since formal exploratory thoracotomy.

               -  No prior chemotherapy or radiation therapy for NSCLC.

          -  ECOG performance status 0-1

          -  Required Initial Laboratory Values (must be submitted within 16 days prior to
             registration):

               -  Granulocytes ≥ 1,500/µl

               -  Platelets ≥ 100,000/µl

               -  Calculated Creatinine Clearance ≥ 20 cc/min

               -  Bilirubin < 1.5 mg/dl

               -  AST (SGOT) < 2 x ULN

               -  INR > 0.8 < 1.2* *Values apply exclusively to patients not being treated with
                  warfarin. Values for patients being treating with warfarin should fall within the
                  following therapeutic range: > 2.0 < 3.0.

        Exclusion Criteria:

          -  Currently active second malignancy other than non-melanoma skin cancers. Patients are
             not considered to have a "currently active" malignancy if they have completed therapy
             and are considered by their physician to be at less than 30% risk of relapse.

          -  Pregnant or nursing because of significant risk to the fetus/infant.

          -  Age <18 years.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  No HIV-positive patients receiving combination anti-retroviral therapy. Because
             patients with immune deficiency are at increased risk of lethal infections when
             treated with marrow-suppressive therapy

          -  One-second forced expiratory volume (FEV1) <50% or hemoglobin-corrected carbon
             monoxide diffusion capacity (DLCO) <50% of predicted, as measured within 21 days of
             study entry

          -  Symptoms of esophageal dysfunction (dysphagia, odynophagia, or inability to swallow
             solid food) within 4 weeks prior to study randomization. Patients must not require
             prophylactic placement of percutaneous enterogastrostomy (PEG) tube or other non-oral
             nutritional supplement methods

          -  Weight loss of > 10% in the past 3 months.