Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054184
Recruitment Status : Unknown
Verified July 2013 by CTI BioPharma.
Recruitment status was:  Active, not recruiting
First Posted : February 6, 2003
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):
CTI BioPharma

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether polyglutamate paclitaxel is more effective than docetaxel in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel with that of docetaxel in treating patients who have progressive non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: docetaxel Drug: paclitaxel poliglumex Phase 3

Detailed Description:


  • Compare the efficacy of polyglutamate paclitaxel (CT-2103) vs docetaxel as second-line therapy, in terms of duration of overall survival, in patients with progressive non-small cell lung cancer.
  • Compare the safety and toxicity of these regimens in these patients.
  • Compare the disease control (stable disease maintained for at least 12 weeks, partial response, or complete response) and progression-free survival of patients treated with these regimens.
  • Compare the improvement in lung cancer symptoms in patients treated with these regimens.
  • Compare the frequency of grade 3 and 4 neurotoxicity, edema, alopecia, and side effects related to corticosteroids in patients treated with these regimens.
  • Determine the percentage of patients who receive at least 4 courses of study treatment.
  • Compare the response rate in patients with measurable disease treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to stage (IV vs other), performance status (0 or 1 vs 2), start of front-line chemotherapy from randomization (less than 16 weeks vs at least 16 weeks), gender, and prior taxane therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive polyglutamate paclitaxel (CT-2103) IV over 10 minutes on day 1.
  • Arm II: Patients receive docetaxel IV over 1 hour on day 1. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 840 patients (420 per treatment arm) will be accrued for this study within 18 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer (NSCLC): A Phase III Study
Study Start Date : January 2003
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Study drug Drug: docetaxel Drug: paclitaxel poliglumex

Primary Outcome Measures :
  1. Saftey [ Time Frame: Baseline to end of treatment ]

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: Basline to EOS ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed non-small cell lung cancer (NSCLC)
  • Documented clinical or radiologic disease progression on or after initial systemic therapy

    • Must have received 1 prior platinum-based systemic therapy for NSCLC
  • Measurable or nonmeasurable disease
  • No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology
  • Brain metastases allowed provided patient received prior standard antitumor therapy for CNS metastases (e.g., whole brain radiotherapy, stereotactic radioablation, or surgery) and the following conditions are met:

    • No prior systemic chemotherapy as a radiosensitizer combined with radiotherapy
    • Obtained stable neurologic function at least 2 weeks before study entry
    • Off steroid therapy or on a tapering regimen
    • Recovered from prior therapy



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Al least 16 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN
  • AST or ALT no greater than 1.5 times ULN


  • Creatinine no greater than 1.5 times ULN


  • No unstable angina
  • No myocardial infarction within the past 6 months
  • No evidence of cardiac conduction abnormalities (e.g., bundle branch block or heart block) unless cardiac status stable for the past 6 months


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No evidence of unstable neurological symptoms in the past 4 weeks (2 weeks for neurological symptoms due to brain metastases)
  • No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid, poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide)
  • No other unstable medical conditions
  • No clinically significant active infection
  • No neuropathy greater than grade 1
  • No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin cancer
  • No circumstance that would preclude study completion or follow-up


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • No prior polyglutamate paclitaxel
  • No prior docetaxel

Endocrine therapy

  • See Disease Characteristics


  • See Disease Characteristics
  • No concurrent radiotherapy


  • See Disease Characteristics
  • Recovered from prior major surgery


  • Recovered from prior therapy
  • More than 2 weeks since prior treatment for NSCLC
  • More than 4 weeks since prior investigational drugs
  • No other concurrent investigational drugs
  • No other concurrent systemic antitumor therapy
  • No concurrent amifostine
  • Concurrent bisphosphonates allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00054184

  Hide Study Locations
United States, Alabama
Clinical Research Consultants, Incorporated
Hoover, Alabama, United States, 35216
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
United States, Arkansas
Highlands Oncology Group - Springdale
Springdale, Arkansas, United States, 72764
United States, California
Pacific Cancer Medical Center, Incorporated
Anaheim, California, United States, 92801
Synergy Hematology/Oncology Medical Associates
Encino, California, United States, 91316
California Cancer Care, Inc.
Greenbrae, California, United States, 94904-2007
California Hematology/Oncology Medical Group
Torrance, California, United States, 90505
United States, Florida
Northwest Oncology and Hematology Associates
Coral Springs, Florida, United States, 33065
Florida Oncology Associates
Jacksonville, Florida, United States, 32207
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
Port Saint Lucie, Florida, United States, 34952
United States, Georgia
Suburban Hematology-Oncology
Snellville, Georgia, United States, 30078-6782
United States, Illinois
Gross Point Medical Center
Skokie, Illinois, United States, 60077
United States, Kentucky
Western Kentucky Hematology/Oncology Group
Paducah, Kentucky, United States, 42003
Kentucky Cancer Clinic
Pikeville, Kentucky, United States, 41501
United States, Missouri
Saint Joseph Oncology, Incorporated
Saint Joseph, Missouri, United States, 64507
United States, Montana
Montana Cancer Specialists
Missoula, Montana, United States, 59807-7877
United States, Nevada
Las Vegas Cancer Center
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Howell, New Jersey, United States, 07731
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
United States, New Mexico
New Mexico Oncology-Hematology Consultants, Limited
Albuquerque, New Mexico, United States, 87109
United States, New York
Queens Medical Associates, PC
Fresh Meadows, New York, United States, 11365
United States, North Carolina
Piedmont Oncology Specialist, II, PLLC
Monroe, North Carolina, United States, 28110
United States, North Dakota
Odyssey Research Services
Bismarck, North Dakota, United States, 58501
United States, Ohio
Gabrail Cancer Center - Canton Office
Canton, Ohio, United States, 44718
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
United States, South Carolina
Charleston Hematology-Oncology, P.A.
Charleston, South Carolina, United States, 29403
Tri County Oncology Associates
Rock Hill, South Carolina, United States, 29732-1119
Santee Hematology Oncology
Sumter, South Carolina, United States, 29150
United States, Tennessee
Family Cancer Center
Collierville, Tennessee, United States, 38017
United States, Texas
Southwest Regional Cancer Center
Austin, Texas, United States, 78705
Richardson, Texas, United States, 75080
United States, Virginia
Danville Hematology and Oncology, Incorporated
Danville, Virginia, United States, 24541
Virginia Oncology Care P.C.
Richlands, Virginia, United States, 24641
United States, Washington
Western Washington Medical Group
Everett, Washington, United States, 98201
Sponsors and Collaborators
CTI BioPharma
Study Chair: Brenda Garrison PPD, Incorporated

Responsible Party: CTI BioPharma Identifier: NCT00054184     History of Changes
Other Study ID Numbers: CTI-PGT302
CDR0000269907 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013

Keywords provided by CTI BioPharma:
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action