A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer
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.
Checked against the public recordLast updated Dec 12, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Washington University School of Medicine
- Interventions being studied
- Drug: Paclitaxel poliglumex; Drug: Carboplatin; Radiation: External beam radiation therapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of California, San FranciscoSan Francisco, California
- Washington Hospital CenterWashington D.C., District of Columbia
- Rush University Medical CollegeChicago, Illinois
- University of KansasLawrence, Kansas
- University of Minnesota, Twin CitiesMinneapolis, Minnesota
- University of Missouri, ColumbiaColumbia, Missouri
- Washington University School of MedicineSt Louis, Missouri
- SUNY Upstate Medical UniversitySyracuse, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 12, 2016. Always confirm current availability with the study team.