Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
NCT ID: NCT00054210
Last Updated: 2020-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
INTERVENTIONAL
2003-01-31
2004-10-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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carboplatin
paclitaxel
paclitaxel poliglumex
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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CTI BioPharma
INDUSTRY
Principal Investigators
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Melinda Bomar
Role: STUDY_CHAIR
PPD, Incorporated
Locations
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Hematology and Oncology Associates of Alabama
Birmingham, Alabama, United States
Clinical Research Consultants, Inc
Hoover, Alabama, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
Synergy Hematology/Oncology Medical Associates
Encino, California, United States
Holy Cross Providence Cancer Center
Mission Hills, California, United States
Clinical Trials and Research Associates, Incorporated
Montebello, California, United States
California Hematology/Oncology Medical Group
Torrance, California, United States
Hematology Oncology, P.C.
Stamford, Connecticut, United States
New Hope Cancer Centers
Hudson, Florida, United States
Omni Healthcare, PA
Melbourne, Florida, United States
MetCare Oncology
Ormond Beach, Florida, United States
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
Port Saint Lucie, Florida, United States
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States
Georgia Cancer Specialists - Tucker
Tucker, Georgia, United States
Silver Cross Hospital
Joliet, Illinois, United States
Gross Point Medical Center
Skokie, Illinois, United States
Kentucky Cancer Clinic
Pikeville, Kentucky, United States
Grand Rapids, Michigan, United States
Hattiesburg Clinic, P.A.
Hattiesburg, Mississippi, United States
Columbia Comprehensive Cancer Care Clinic
Columbia, Missouri, United States
Bond Clinic
Rolla, Missouri, United States
Las Vegas Cancer Center
Las Vegas, Nevada, United States
Summit Medical Group, P.A.
Summit, New Jersey, United States
Gabrail Cancer Center - Canton Office
Canton, Ohio, United States
Oklahoma Oncology, Inc. - St. John Campus
Tulsa, Oklahoma, United States
Charleston Cancer Center
Charleston, South Carolina, United States
Santee Hematology Oncology
Sumter, South Carolina, United States
Clarksville Regional Hematology/Oncology Group
Clarksville, Tennessee, United States
Family Cancer Center
Collierville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Cancer Therapy and Research Center
San Antonio, Texas, United States
Virginia Oncology Care P.C.
Richlands, Virginia, United States
Highline Medical Oncology
Burien, Washington, United States
Rainier Oncology
Puyallup, Washington, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
Countries
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Other Identifiers
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CDR0000269910
Identifier Type: REGISTRY
Identifier Source: secondary_id
CTI-PGT303
Identifier Type: -
Identifier Source: org_study_id
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