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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
carboplatin
paclitaxel
paclitaxel poliglumex
Sponsored by
CTI BioPharma
About
Eligibility
Locations
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 IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 2 Life expectancy Not specified 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) 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) Renal Creatinine no greater than 1.5 times ULN Cardiovascular 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 Neurologic 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) Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy No prior systemic biologic agent for lung cancer Chemotherapy See Disease Characteristics No prior systemic therapy for lung cancer including radiosensitizing agents Endocrine therapy See Disease Characteristics Radiotherapy See Disease Characteristics No concurrent radiotherapy Surgery See Disease Characteristics Recovered from prior major surgery Other 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

Sites / Locations

  • Hematology and Oncology Associates of Alabama
  • Clinical Research Consultants, Inc
  • Arizona Clinical Research Center
  • Synergy Hematology/Oncology Medical Associates
  • Holy Cross Providence Cancer Center
  • Clinical Trials and Research Associates, Incorporated
  • California Hematology/Oncology Medical Group
  • Hematology Oncology, P.C.
  • New Hope Cancer Centers
  • Omni Healthcare, PA
  • MetCare Oncology
  • Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
  • Northwest Georgia Oncology Centers, P.C.
  • Georgia Cancer Specialists - Tucker
  • Silver Cross Hospital
  • Gross Point Medical Center
  • Kentucky Cancer Clinic
  • Hattiesburg Clinic, P.A.
  • Columbia Comprehensive Cancer Care Clinic
  • Bond Clinic
  • Las Vegas Cancer Center
  • Summit Medical Group, P.A.
  • Gabrail Cancer Center - Canton Office
  • Oklahoma Oncology, Inc. - St. John Campus
  • Charleston Cancer Center
  • Santee Hematology Oncology
  • Clarksville Regional Hematology/Oncology Group
  • Family Cancer Center
  • University of Texas - MD Anderson Cancer Center
  • Cancer Therapy and Research Center
  • Virginia Oncology Care P.C.
  • Highline Medical Oncology
  • Rainier Oncology
  • Cross Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

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
NCT00054210
Brief Title
Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
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 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

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. 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.
Detailed Description
OBJECTIVES: 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.

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 IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
paclitaxel poliglumex

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 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 2 Life expectancy Not specified 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) 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) Renal Creatinine no greater than 1.5 times ULN Cardiovascular 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 Neurologic 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) Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy No prior systemic biologic agent for lung cancer Chemotherapy See Disease Characteristics No prior systemic therapy for lung cancer including radiosensitizing agents Endocrine therapy See Disease Characteristics Radiotherapy See Disease Characteristics No concurrent radiotherapy Surgery See Disease Characteristics Recovered from prior major surgery Other 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melinda Bomar
Organizational Affiliation
PPD, Incorporated
Official's Role
Study Chair
Facility Information:
Facility Name
Hematology and Oncology Associates of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Clinical Research Consultants, Inc
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
Synergy Hematology/Oncology Medical Associates
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Holy Cross Providence Cancer Center
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Clinical Trials and Research Associates, Incorporated
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
California Hematology/Oncology Medical Group
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Hematology Oncology, P.C.
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
New Hope Cancer Centers
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Omni Healthcare, PA
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
MetCare Oncology
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
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
Northwest Georgia Oncology Centers, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Georgia Cancer Specialists - Tucker
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
Silver Cross Hospital
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60432
Country
United States
Facility Name
Gross Point Medical Center
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Kentucky Cancer Clinic
City
Pikeville
State/Province
Kentucky
ZIP/Postal Code
41501
Country
United States
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Hattiesburg Clinic, P.A.
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Columbia Comprehensive Cancer Care Clinic
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Bond Clinic
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Las Vegas Cancer Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Summit Medical Group, P.A.
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Gabrail Cancer Center - Canton Office
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Oklahoma Oncology, Inc. - St. John Campus
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Charleston Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Santee Hematology Oncology
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
Clarksville Regional Hematology/Oncology Group
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Facility Name
Family Cancer Center
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Cancer Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Oncology Care P.C.
City
Richlands
State/Province
Virginia
ZIP/Postal Code
24641
Country
United States
Facility Name
Highline Medical Oncology
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Rainier Oncology
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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