Lung Cancer Clinical Trial
Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
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.
Full 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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 35 Locations for this study
Birmingham Alabama, 35243, United States
Hoover Alabama, 35216, United States
Tucson Arizona, 85712, United States
Encino California, 91316, United States
Mission Hills California, 91345, United States
Montebello California, 90640, United States
Torrance California, 90505, United States
Stamford Connecticut, 06902, United States
Hudson Florida, 34667, United States
Melbourne Florida, 32901, United States
Ormond Beach Florida, 32174, United States
Port Saint Lucie Florida, 34952, United States
Marietta Georgia, 30060, United States
Tucker Georgia, 30084, United States
Joliet Illinois, 60432, United States
Skokie Illinois, 60077, United States
Pikeville Kentucky, 41501, United States
Grand Rapids Michigan, 49503, United States
Hattiesburg Mississippi, 39401, United States
Columbia Missouri, 65201, United States
Rolla Missouri, 65401, United States
Las Vegas Nevada, 89102, United States
Summit New Jersey, 07901, United States
Canton Ohio, 44718, United States
Tulsa Oklahoma, 74104, United States
Charleston South Carolina, 29406, United States
Sumter South Carolina, 29150, United States
Clarksville Tennessee, 37043, United States
Collierville Tennessee, 38017, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Richlands Virginia, 24641, United States
Burien Washington, 98166, United States
Puyallup Washington, 98372, United States
Edmonton Alberta, T6G 1, Canada
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.