A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Paclitaxel poliglumex; Carboplatin; External beam radiation therapy
Intervention MeSH terms: Paclitaxel; Carboplatin; Paclitaxel poliglumex
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is intended to evaluate the role of paclitaxel poliglumex and carboplatin in the
      treatment of unresectable Stage III non-small cell lung cancer along with radiation therapy
      in a multi-institutional trial. Consolidation chemotherapy with paclitaxel poliglumex and
      carboplatin will follow the completion of chemoradiation.
    

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.