Status:
TERMINATED
A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
CTI BioPharma
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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-insti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00352690
Start Date
April 1 2006
End Date
June 1 2008
Last Update
December 12 2016
Active Locations (8)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Rush University Medical College
Chicago, Illinois, United States
4
University of Kansas
Lawrence, Kansas, United States, 66045