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 recurrentnon-small cell lung cancer.

PURPOSE: Randomizedphase 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.

Condition	Treatment or Intervention	Phase
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer	Drug: carboplatin  Drug: paclitaxel  Drug: polyglutamate paclitaxel  Procedure: chemotherapy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Alabama
      Clinical Research Consultants, Inc, Hoover,  Alabama,  35216,  United States
      Hematology and Oncology Associates of Alabama, Birmingham,  Alabama,  35243,  United States
Arizona
      Arizona Clinical Research Center, Tucson,  Arizona,  85712,  United States
California
      California Hematology/Oncology Medical Group, Torrance,  California,  90505,  United States
      Clinical Trials and Research Associates, Incorporated, Montebello,  California,  90640,  United States
      Holy Cross Providence Cancer Center, Mission Hills,  California,  91345,  United States
      Synergy Hematology/Oncology Medical Associates, Encino,  California,  91316,  United States
Connecticut
      Hematology Oncology, P.C., Stamford,  Connecticut,  06902,  United States
Florida
      Hematology Oncology Associates of theTreasure Coast - Port St. Lucie, Port Saint Lucie,  Florida,  34952,  United States
      MetCare Oncology, Ormond Beach,  Florida,  32174,  United States
      New Hope Cancer Centers, Hudson,  Florida,  34667,  United States
      Omni Healthcare, PA, Melbourne,  Florida,  32901,  United States
Georgia
      Georgia Cancer Specialists - Tucker, Tucker,  Georgia,  30084,  United States
      Northwest Georgia Oncology Centers, P.C., Marietta,  Georgia,  30060,  United States
Illinois
      Gross Point Medical Center, Skokie,  Illinois,  60077,  United States
      Silver Cross Hospital, Joliet,  Illinois,  60432,  United States
Kentucky
      Kentucky Cancer Clinic, Pikeville,  Kentucky,  41501,  United States
Michigan
      Grand Rapids,  Michigan,  49503,  United States
Mississippi
      Hattiesburg Clinic, P.A., Hattiesburg,  Mississippi,  39401,  United States
Missouri
      Bond Clinic, Rolla,  Missouri,  65401,  United States
      Columbia Comprehensive Cancer Care Clinic, Columbia,  Missouri,  65201,  United States
Nevada
      Las Vegas Cancer Center, Las Vegas,  Nevada,  89102,  United States
New Jersey
      Summit Medical Group, P.A., Summit,  New Jersey,  07901,  United States
Ohio
      Gabrail Cancer Center - Canton Office, Canton,  Ohio,  44718,  United States
Oklahoma
      Oklahoma Oncology, Inc. - St. John Campus, Tulsa,  Oklahoma,  74104,  United States
South Carolina
      Charleston Cancer Center, Charleston,  South Carolina,  29406,  United States
      Santee Hematology Oncology, Sumter,  South Carolina,  29150,  United States
Tennessee
      Clarksville Regional Hematology/Oncology Group, Clarksville,  Tennessee,  37043,  United States
      Family Cancer Center, Collierville,  Tennessee,  38017,  United States
Texas
      Cancer Therapy and Research Center, San Antonio,  Texas,  78229,  United States
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States
Virginia
      Virginia Oncology Care P.C., Richlands,  Virginia,  24641,  United States
Washington
      Highline Medical Oncology, Burien,  Washington,  98166,  United States
      Rainier Oncology, Puyallup,  Washington,  98372,  United States
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada

Study chairs or principal investigators

Melinda Bomar,  Study Chair,  PPD   

Study ID Numbers:  CDR0000269910; CTI-PGT303
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  February 5, 2003
ClinicalTrials.gov Identifier:  NCT00054210
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08