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

October 2, 2020 updated by: CTI BioPharma

CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer (NSCLC): A Phase III Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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

Enrollment (Anticipated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Al least 16 weeks

Hematopoietic

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

Hepatic

  • 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

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

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

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • See Disease Characteristics
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior major surgery

Other

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study drug
Drug: docetaxel
Drug: paclitaxel poliglumex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Saftey
Time Frame: Baseline to end of treatment
Baseline to end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy
Time Frame: Basline to EOS
Basline to EOS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CTI BioPharma

Investigators

  • Study Chair: Brenda Garrison, PPD, Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2003

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

February 5, 2003

First Submitted That Met QC Criteria

February 5, 2003

First Posted (Estimate)

February 6, 2003

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTI-PGT302
  • CDR0000269907 (Registry Identifier: PDQ (Physician Data Query))
  • CWRU-CTI-1503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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