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

NCT ID: NCT00352690

Last Updated: 2016-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1 (first 12 eligible patients)

Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.

Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.

Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.

Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.

Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.

Group Type OTHER

Paclitaxel poliglumex

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

External beam radiation therapy

Intervention Type RADIATION

Cohort 2 (remaining patients)

Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.

Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.

Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.

Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.

Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.

Group Type EXPERIMENTAL

Paclitaxel poliglumex

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

External beam radiation therapy

Intervention Type RADIATION

Interventions

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Paclitaxel poliglumex

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

External beam radiation therapy

Intervention Type RADIATION

Other Intervention Names

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Xyotax Paraplatin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CTI BioPharma

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ramaswamy Govindan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Rush University Medical College

Chicago, Illinois, United States

Site Status

University of Kansas

Lawrence, Kansas, United States

Site Status

University of Minnesota, Twin Cities

Minneapolis, Minnesota, United States

Site Status

University of Missouri, Columbia

Columbia, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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05-1195

Identifier Type: -

Identifier Source: org_study_id