Lung Cancer Clinical Trial

Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive 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. It is not yet known whether polyglutamate paclitaxel is more effective than docetaxel in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel with that of docetaxel in treating patients who have progressive non-small cell lung cancer.

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Full Description

OBJECTIVES:

Compare the efficacy of polyglutamate paclitaxel (CT-2103) vs docetaxel as second-line therapy, in terms of duration of overall survival, in patients with progressive non-small cell lung cancer.
Compare the safety and toxicity of these regimens in these patients.
Compare the disease control (stable disease maintained for at least 12 weeks, partial response, or complete response) and progression-free survival of patients treated with these regimens.
Compare the improvement in lung cancer symptoms in patients treated with these regimens.
Compare the frequency of grade 3 and 4 neurotoxicity, edema, alopecia, and side effects related to corticosteroids in patients treated with these regimens.
Determine the percentage of patients who receive at least 4 courses of study treatment.
Compare the response rate in patients with measurable disease treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to stage (IV vs other), performance status (0 or 1 vs 2), start of front-line chemotherapy from randomization (less than 16 weeks vs at least 16 weeks), gender, and prior taxane therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive polyglutamate paclitaxel (CT-2103) IV over 10 minutes on day 1.
Arm II: Patients receive docetaxel IV over 1 hour on day 1. In both arms, courses repeat every 21 days 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 840 patients (420 per treatment arm) will be accrued for this study within 18 months.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer (NSCLC)

Documented clinical or radiologic disease progression on or after initial systemic therapy

Must have received 1 prior platinum-based systemic therapy for NSCLC
Measurable or nonmeasurable disease
No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology

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:

No prior systemic chemotherapy as a radiosensitizer combined with radiotherapy
Obtained stable neurologic function 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 0-2

Life expectancy

Al least 16 weeks

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)
Alkaline phosphatase no greater than 2.5 times ULN
AST or ALT no greater than 1.5 times ULN

Renal

Creatinine no greater than 1.5 times ULN

Cardiovascular

No unstable angina
No myocardial infarction within the past 6 months
No evidence of cardiac conduction abnormalities (e.g., bundle branch block or heart block) unless cardiac status stable for the past 6 months

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No evidence of unstable neurological symptoms in the past 4 weeks (2 weeks for neurological symptoms due to brain metastases)
No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid, poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide)
No other unstable medical conditions
No clinically significant active infection
No neuropathy greater than grade 1
No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin cancer
No circumstance that would preclude study completion or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics
No prior polyglutamate paclitaxel
No prior docetaxel

Endocrine therapy

See Disease Characteristics

Radiotherapy

See Disease Characteristics
No concurrent radiotherapy

Surgery

See Disease Characteristics
Recovered from prior major surgery

Other

Recovered from prior therapy
More than 2 weeks since prior treatment for NSCLC
More than 4 weeks since prior investigational drugs
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

Estimated Enrollment:

350

Study ID:

NCT00054184

Recruitment Status:

Terminated

Sponsor:

CTI BioPharma

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There are 35 Locations for this study

See Locations Near You

Clinical Research Consultants, Incorporated
Hoover Alabama, 35216, United States
Arizona Clinical Research Center
Tucson Arizona, 85712, United States
Highlands Oncology Group - Springdale
Springdale Arkansas, 72764, United States
Pacific Cancer Medical Center, Incorporated
Anaheim California, 92801, United States
Synergy Hematology/Oncology Medical Associates
Encino California, 91316, United States
California Cancer Care, Inc.
Greenbrae California, 94904, United States
California Hematology/Oncology Medical Group
Torrance California, 90505, United States
Northwest Oncology and Hematology Associates
Coral Springs Florida, 33065, United States
Florida Oncology Associates
Jacksonville Florida, 32207, United States
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
Port Saint Lucie Florida, 34952, United States
Suburban Hematology-Oncology
Snellville Georgia, 30078, United States
Gross Point Medical Center
Skokie Illinois, 60077, United States
Western Kentucky Hematology/Oncology Group
Paducah Kentucky, 42003, United States
Kentucky Cancer Clinic
Pikeville Kentucky, 41501, United States
Saint Joseph Oncology, Incorporated
Saint Joseph Missouri, 64507, United States
Montana Cancer Specialists
Missoula Montana, 59807, United States
Las Vegas Cancer Center
Las Vegas Nevada, 89102, United States

Howell New Jersey, 07731, United States
Morristown Memorial Hospital
Morristown New Jersey, 07962, United States
New Mexico Oncology-Hematology Consultants, Limited
Albuquerque New Mexico, 87109, United States
Queens Medical Associates, PC
Fresh Meadows New York, 11365, United States
Piedmont Oncology Specialist, II, PLLC
Monroe North Carolina, 28110, United States
Odyssey Research Services
Bismarck North Dakota, 58501, United States
Gabrail Cancer Center - Canton Office
Canton Ohio, 44718, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Pennsylvania Oncology Hematology Associates
Philadelphia Pennsylvania, 19106, United States
Charleston Hematology-Oncology, P.A.
Charleston South Carolina, 29403, United States
Tri County Oncology Associates
Rock Hill South Carolina, 29732, United States
Santee Hematology Oncology
Sumter South Carolina, 29150, United States
Family Cancer Center
Collierville Tennessee, 38017, United States
Southwest Regional Cancer Center
Austin Texas, 78705, United States

Richardson Texas, 75080, United States
Danville Hematology and Oncology, Incorporated
Danville Virginia, 24541, United States
Virginia Oncology Care P.C.
Richlands Virginia, 24641, United States
Western Washington Medical Group
Everett Washington, 98201, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

350

Study ID:

NCT00054184

Recruitment Status:

Terminated

Sponsor:


CTI BioPharma

How clear is this clinincal trial information?

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