A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer
- 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
- 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.
- 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
- 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
- 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.