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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Study ID:

NCT00054210

Recruitment Status:

Terminated

Sponsor:

CTI BioPharma

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 35 Locations for this study

See Locations Near You

Hematology and Oncology Associates of Alabama
Birmingham Alabama, 35243, United States
Clinical Research Consultants, Inc
Hoover Alabama, 35216, United States
Arizona Clinical Research Center
Tucson Arizona, 85712, United States
Synergy Hematology/Oncology Medical Associates
Encino California, 91316, United States
Holy Cross Providence Cancer Center
Mission Hills California, 91345, United States
Clinical Trials and Research Associates, Incorporated
Montebello California, 90640, United States
California Hematology/Oncology Medical Group
Torrance California, 90505, United States
Hematology Oncology, P.C.
Stamford Connecticut, 06902, United States
New Hope Cancer Centers
Hudson Florida, 34667, United States
Omni Healthcare, PA
Melbourne Florida, 32901, United States
MetCare Oncology
Ormond Beach Florida, 32174, United States
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
Port Saint Lucie Florida, 34952, United States
Northwest Georgia Oncology Centers, P.C.
Marietta Georgia, 30060, United States
Georgia Cancer Specialists - Tucker
Tucker Georgia, 30084, United States
Silver Cross Hospital
Joliet Illinois, 60432, United States
Gross Point Medical Center
Skokie Illinois, 60077, United States
Kentucky Cancer Clinic
Pikeville Kentucky, 41501, United States

Grand Rapids Michigan, 49503, United States
Hattiesburg Clinic, P.A.
Hattiesburg Mississippi, 39401, United States
Columbia Comprehensive Cancer Care Clinic
Columbia Missouri, 65201, United States
Bond Clinic
Rolla Missouri, 65401, United States
Las Vegas Cancer Center
Las Vegas Nevada, 89102, United States
Summit Medical Group, P.A.
Summit New Jersey, 07901, United States
Gabrail Cancer Center - Canton Office
Canton Ohio, 44718, United States
Oklahoma Oncology, Inc. - St. John Campus
Tulsa Oklahoma, 74104, United States
Charleston Cancer Center
Charleston South Carolina, 29406, United States
Santee Hematology Oncology
Sumter South Carolina, 29150, United States
Clarksville Regional Hematology/Oncology Group
Clarksville Tennessee, 37043, United States
Family Cancer Center
Collierville Tennessee, 38017, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Cancer Therapy and Research Center
San Antonio Texas, 78229, United States
Virginia Oncology Care P.C.
Richlands Virginia, 24641, United States
Highline Medical Oncology
Burien Washington, 98166, United States
Rainier Oncology
Puyallup Washington, 98372, United States
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Study ID:

NCT00054210

Recruitment Status:

Terminated

Sponsor:


CTI BioPharma

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider