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.

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Carboplatin; Drug: Paclitaxel poliglumex; Radiation: External beam radiation therapy

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Illinois
    • Chicago, Illinois, United States
      • Rush University Medical College
  • Kansas
    • Lawrence, Kansas, United States, 66045
      • University of Kansas
  • Minnesota
    • Minneapolis, Minnesota, United States
      • University of Minnesota, Twin Cities
  • Missouri
    • Columbia, Missouri, United States, 65211
      • University of Missouri, Columbia
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Drug: Carboplatin; Other Names: Paraplatin; Drug: Paclitaxel poliglumex; Other Names: Xyotax; Radiation: External beam radiation therapy
EXPERIMENTAL: 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.	Drug: Carboplatin; Other Names: Paraplatin; Drug: Paclitaxel poliglumex; Other Names: Xyotax; Radiation: External beam radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Rate	OS = time from patient registration to death of all causes; Estimated using Kaplan Meier	6 months
Overall Survival (OS)	OS = time from patient registration to death of all causes	Completion of follow-up (follow-up ranged from 3 months to 6 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure-free Survival (FFS) Rate	The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first); Estimated using Kaplan Meier	6 months
Failure-free Survival (FFS)	The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)	Completion of follow-up (follow-up ranged from 3 months to 6 years)
Response Rates	Overall best response using RECIST 1.0	4 years
Incidence and Severity of Radiation-induced Esophagitis		30 days following completion of treatment (approximately 114 days)
Incidence and Severity of Radiation-induced Pneumonitis		30 days following completion of treatment (approximately 114 days)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: CTI BioPharma

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (ACTUAL): June 1, 2008
• Study Completion (ACTUAL): June 1, 2008

Study Registration Dates

• First Submitted: July 14, 2006
• First Submitted That Met QC Criteria: July 14, 2006
• First Posted (ESTIMATE): July 17, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Paclitaxel poliglumex
• Other Study ID Numbers: 05-1195