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Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: February 5, 2003
Last updated: February 23, 2011
Last verified: July 2004

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 whether polyglutamate paclitaxel is more effective than gemcitabine or vinorelbine in treating non-small cell lung cancer.

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

Condition Intervention Phase
Lung Cancer
Drug: gemcitabine hydrochloride
Drug: paclitaxel poliglumex
Drug: vinorelbine tartrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: CT-2103 vs Gemcitabine or Vinorelbine for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2003
Detailed Description:


  • Compare the efficacy of polyglutamate paclitaxel (CT-2103) vs gemcitabine or vinorelbine, 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 safety of these regimens in these patients.
  • 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 on day 1 every 21 days.
  • Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 every 28 days OR vinorelbine IV over 6-10 minutes on days 1, 8, and 15 every 21 days.

Treatment repeats in both arms for up to 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.


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 neurologic symptoms within the past 4 weeks (2 weeks for neurologic 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 chemotherapy 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00054197

United States, Alabama
Cooper Green Hospital
Birmingham, Alabama, United States, 35233
United States, California
Medical Oncology/Hematology
Gilroy, California, United States, 95020
United States, Florida
Northwest Oncology and Hematology Associates
Coral Springs, Florida, United States, 33065
United States, Illinois
Midwest Cancer Research Group, Incorporated
Skokie, Illinois, United States, 60077
United States, Nevada
Medschool Associates North
Reno, Nevada, United States, 89502
United States, New York
New York Oncology Hematology, P.C. - Latham
Latham, New York, United States, 12110-0610
United States, North Dakota
Clinical Research Services
Bismarck, North Dakota, United States, 58501
United States, South Carolina
Charleston Hematology-Oncology, P.A.
Charleston, South Carolina, United States, 29403
United States, Washington
Western Washington Medical Group
Everett, Washington, United States, 98201
Western Washington Oncology, Incorporated
Olympia, Washington, United States, 98502
Sponsors and Collaborators
CTI BioPharma
Study Chair: Meghann Smith PPD, Incorporated
  More Information

Publications: Identifier: NCT00054197     History of Changes
Other Study ID Numbers: CDR0000269908
Study First Received: February 5, 2003
Last Updated: February 23, 2011

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
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on March 29, 2017