Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent 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: NCT00054210
Recruitment Status : Unknown
Verified July 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 6, 2003
Last Update Posted : July 24, 2008
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating stage IIIB, stage IV, or recurrent non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel plus carboplatin to that of paclitaxel plus carboplatin in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

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

Detailed Description:


  • Compare the efficacy of polyglutamate paclitaxel (CT-2103) and carboplatin vs paclitaxel and carboplatin, in terms of duration of overall survival, in patients with stage IIIB or IV or recurrent non-small cell lung cancer who have a performance status of 2.
  • Compare the disease control (percentage of patients with no disease progression for at least 12 weeks) and time to progression in patients treated with these regimens.
  • Compare the response rate in patients with measurable disease treated with these regimens.
  • Compare the improvement in lung cancer symptoms in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, disease stage (IV vs other), geographic location (US vs Western Europe and Canada vs the rest of the world), and prior brain metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive polyglutamate paclitaxel (CT-2103) IV over 10 minutes and carboplatin IV over 30 minutes on day 1.
  • Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.

Treatment repeats in both arms every 21 days for 6 courses 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 370 patients (185 per treatment arm) will be accrued for this study within 13 months.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CT-2103/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study
Study Start Date : January 2003

Resource links provided by the National Library of Medicine

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

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 or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

    • Locally advanced or recurrent disease previously treated with radiotherapy and/or surgery
    • Stage IIIB and not a candidate for combined modality therapy
    • Stage IV
  • No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology
  • Cytological diagnosis must be based on the following:

    • No cellular diagnosis by sputum cytology alone
    • Cytologic specimens obtained from brushings, washings, or needle aspiration of a defined lesion or pleural effusion are acceptable
  • Measurable or nonmeasurable disease
  • 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:

    • Neurologic function stable for 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 2

Life expectancy

  • Not specified


  • 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)
  • SGOT/SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 2.5 times ULN (except for laboratory documentation that demonstrates bone origin)


  • Creatinine no greater than 1.5 times ULN


  • No unstable angina
  • No myocardial infarction within the past 6 months
  • Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for at least 6 months prior to study entry


  • See Disease Characteristics
  • No neuropathy greater than grade 1
  • No evidence of unstable neurological symptoms within the past 4 weeks (2 weeks for neurological symptoms due to brain metastases)


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid, poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide)
  • No clinically significant active infection
  • No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin cancer
  • No other unstable medical conditions
  • No circumstance that would preclude study completion or follow-up


Biologic therapy

  • No prior systemic biologic agent for lung cancer


  • See Disease Characteristics
  • No prior systemic therapy for lung cancer including radiosensitizing agents

Endocrine therapy

  • See Disease Characteristics


  • See Disease Characteristics
  • No concurrent radiotherapy


  • See Disease Characteristics
  • Recovered from prior major surgery


  • More than 12 weeks since prior participation in any research study or treatment with investigational drugs
  • Recovered from prior investigational therapy or stable for 4 weeks before study treatment
  • 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): NCT00054210

  Hide Study Locations
United States, Alabama
Hematology and Oncology Associates of Alabama
Birmingham, Alabama, United States, 35243
Clinical Research Consultants, Inc
Hoover, Alabama, United States, 35216
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
United States, California
Synergy Hematology/Oncology Medical Associates
Encino, California, United States, 91316
Holy Cross Providence Cancer Center
Mission Hills, California, United States, 91345
Clinical Trials and Research Associates, Incorporated
Montebello, California, United States, 90640
California Hematology/Oncology Medical Group
Torrance, California, United States, 90505
United States, Connecticut
Hematology Oncology, P.C.
Stamford, Connecticut, United States, 06902
United States, Florida
New Hope Cancer Centers
Hudson, Florida, United States, 34667
Omni Healthcare, PA
Melbourne, Florida, United States, 32901
MetCare Oncology
Ormond Beach, Florida, United States, 32174
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
Port Saint Lucie, Florida, United States, 34952
United States, Georgia
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States, 30060
Georgia Cancer Specialists - Tucker
Tucker, Georgia, United States, 30084
United States, Illinois
Silver Cross Hospital
Joliet, Illinois, United States, 60432
Gross Point Medical Center
Skokie, Illinois, United States, 60077
United States, Kentucky
Kentucky Cancer Clinic
Pikeville, Kentucky, United States, 41501
United States, Michigan
Grand Rapids, Michigan, United States, 49503
United States, Mississippi
Hattiesburg Clinic, P.A.
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Columbia Comprehensive Cancer Care Clinic
Columbia, Missouri, United States, 65201
Bond Clinic
Rolla, Missouri, United States, 65401
United States, Nevada
Las Vegas Cancer Center
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Summit Medical Group, P.A.
Summit, New Jersey, United States, 07901
United States, Ohio
Gabrail Cancer Center - Canton Office
Canton, Ohio, United States, 44718
United States, Oklahoma
Oklahoma Oncology, Inc. - St. John Campus
Tulsa, Oklahoma, United States, 74104
United States, South Carolina
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
Santee Hematology Oncology
Sumter, South Carolina, United States, 29150
United States, Tennessee
Clarksville Regional Hematology/Oncology Group
Clarksville, Tennessee, United States, 37043
Family Cancer Center
Collierville, Tennessee, United States, 38017
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Oncology Care P.C.
Richlands, Virginia, United States, 24641
United States, Washington
Highline Medical Oncology
Burien, Washington, United States, 98166
Rainier Oncology
Puyallup, Washington, United States, 98372
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
CTI BioPharma
Study Chair: Melinda Bomar PPD, Incorporated Identifier: NCT00054210     History of Changes
Other Study ID Numbers: CDR0000269910
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: July 2004

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV 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