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TerminatedPhase 2NCT00352690
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPaclitaxel poliglumex and Carboplatin

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 12, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?Washington University School of Medicine

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→Locally advanced→
Treatment approach
Chemotherapy→Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

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