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

Stopped early · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID: NCT00352690
Run by: Washington University School of Medicine
People needed: 10
Starts: 2006-04-01
Expected to finish: 2008-06-01
Last updated by the study team: 2016-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of California, San Francisco — San Francisco, California, United States
Washington Hospital Center — Washington D.C., District of Columbia, United States
Rush University Medical College — Chicago, Illinois, United States
University of Kansas — Lawrence, Kansas, United States
University of Minnesota, Twin Cities — Minneapolis, Minnesota, United States
University of Missouri, Columbia — Columbia, Missouri, United States
Washington University School of Medicine — St Louis, Missouri, United States
SUNY Upstate Medical University — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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