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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
docetaxel
paclitaxel poliglumex
Sponsored by
CTI BioPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Consultants, Incorporated
  • Arizona Clinical Research Center
  • Highlands Oncology Group - Springdale
  • Pacific Cancer Medical Center, Incorporated
  • Synergy Hematology/Oncology Medical Associates
  • California Cancer Care, Inc.
  • California Hematology/Oncology Medical Group
  • Northwest Oncology and Hematology Associates
  • Florida Oncology Associates
  • Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
  • Suburban Hematology-Oncology
  • Gross Point Medical Center
  • Western Kentucky Hematology/Oncology Group
  • Kentucky Cancer Clinic
  • Saint Joseph Oncology, Incorporated
  • Montana Cancer Specialists
  • Las Vegas Cancer Center
  • Morristown Memorial Hospital
  • New Mexico Oncology-Hematology Consultants, Limited
  • Queens Medical Associates, PC
  • Piedmont Oncology Specialist, II, PLLC
  • Odyssey Research Services
  • Gabrail Cancer Center - Canton Office
  • Ireland Cancer Center
  • Pennsylvania Oncology Hematology Associates
  • Charleston Hematology-Oncology, P.A.
  • Tri County Oncology Associates
  • Santee Hematology Oncology
  • Family Cancer Center
  • Southwest Regional Cancer Center
  • Danville Hematology and Oncology, Incorporated
  • Virginia Oncology Care P.C.
  • Western Washington Medical Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study drug

Arm Description

Outcomes

Primary Outcome Measures

Saftey

Secondary Outcome Measures

Efficacy

Full Information

First Posted
February 5, 2003
Last Updated
October 2, 2020
Sponsor
CTI BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT00054184
Brief Title
Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
Official Title
CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer (NSCLC): A Phase III Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Study Start Date
January 2003 (Actual)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CTI BioPharma

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study drug
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
paclitaxel poliglumex
Primary Outcome Measure Information:
Title
Saftey
Time Frame
Baseline to end of treatment
Secondary Outcome Measure Information:
Title
Efficacy
Time Frame
Basline to EOS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda Garrison
Organizational Affiliation
PPD, Incorporated
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Research Consultants, Incorporated
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Highlands Oncology Group - Springdale
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
Pacific Cancer Medical Center, Incorporated
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Synergy Hematology/Oncology Medical Associates
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
California Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904-2007
Country
United States
Facility Name
California Hematology/Oncology Medical Group
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Northwest Oncology and Hematology Associates
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
Country
United States
Facility Name
Florida Oncology Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Suburban Hematology-Oncology
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078-6782
Country
United States
Facility Name
Gross Point Medical Center
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Western Kentucky Hematology/Oncology Group
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Kentucky Cancer Clinic
City
Pikeville
State/Province
Kentucky
ZIP/Postal Code
41501
Country
United States
Facility Name
Saint Joseph Oncology, Incorporated
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Montana Cancer Specialists
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7877
Country
United States
Facility Name
Las Vegas Cancer Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
City
Howell
State/Province
New Jersey
ZIP/Postal Code
07731
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
New Mexico Oncology-Hematology Consultants, Limited
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Queens Medical Associates, PC
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11365
Country
United States
Facility Name
Piedmont Oncology Specialist, II, PLLC
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28110
Country
United States
Facility Name
Odyssey Research Services
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Gabrail Cancer Center - Canton Office
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Pennsylvania Oncology Hematology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Charleston Hematology-Oncology, P.A.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Tri County Oncology Associates
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732-1119
Country
United States
Facility Name
Santee Hematology Oncology
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
Family Cancer Center
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
Southwest Regional Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Danville Hematology and Oncology, Incorporated
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Virginia Oncology Care P.C.
City
Richlands
State/Province
Virginia
ZIP/Postal Code
24641
Country
United States
Facility Name
Western Washington Medical Group
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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