Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Cell Therapeutics
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00054184

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: docetaxel Drug: paclitaxel poliglumex	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer (NSCLC): A Phase III Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Docetaxel Paclitaxel Poliglumex

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

January 2003

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054184

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Locations

United States, Alabama
Clinical Research Consultants, Incorporated
Hoover, Alabama, United States, 35216
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
United States, Arkansas
Highlands Oncology Group - Springdale
Springdale, Arkansas, United States, 72764
United States, California
California Cancer Care, Inc.
Greenbrae, California, United States, 94904-2007
California Hematology/Oncology Medical Group
Torrance, California, United States, 90505
Pacific Cancer Medical Center, Incorporated
Anaheim, California, United States, 92801
Synergy Hematology/Oncology Medical Associates
Encino, California, United States, 91316
United States, Florida
Florida Oncology Associates
Jacksonville, Florida, United States, 32207
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
Port Saint Lucie, Florida, United States, 34952
Northwest Oncology and Hematology Associates
Coral Springs, Florida, United States, 33065
United States, Georgia
Suburban Hematology-Oncology
Snellville, Georgia, United States, 30078-6782
United States, Illinois
Gross Point Medical Center
Skokie, Illinois, United States, 60077
United States, Kentucky
Kentucky Cancer Clinic
Pikeville, Kentucky, United States, 41501
Western Kentucky Hematology/Oncology Group
Paducah, Kentucky, United States, 42003
United States, Missouri
Saint Joseph Oncology, Incorporated
Saint Joseph, Missouri, United States, 64507
United States, Montana
Montana Cancer Specialists
Missoula, Montana, United States, 59807-7877
United States, Nevada
Las Vegas Cancer Center
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962

Howell, New Jersey, United States, 07731
United States, New Mexico
New Mexico Oncology-Hematology Consultants, Limited
Albuquerque, New Mexico, United States, 87109
United States, New York
Queens Medical Associates, PC
Fresh Meadows, New York, United States, 11365
United States, North Carolina
Piedmont Oncology Specialist, II, PLLC
Monroe, North Carolina, United States, 28110
United States, North Dakota
Odyssey Research Services
Bismarck, North Dakota, United States, 58501
United States, Ohio
Gabrail Cancer Center - Canton Office
Canton, Ohio, United States, 44718
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
United States, South Carolina
Charleston Hematology-Oncology, P.A.
Charleston, South Carolina, United States, 29403
Santee Hematology Oncology
Sumter, South Carolina, United States, 29150
Tri County Oncology Associates
Rock Hill, South Carolina, United States, 29732-1119
United States, Tennessee
Family Cancer Center
Collierville, Tennessee, United States, 38017
United States, Texas

Richardson, Texas, United States, 75080
Southwest Regional Cancer Center
Austin, Texas, United States, 78705
United States, Virginia
Danville Hematology and Oncology, Incorporated
Danville, Virginia, United States, 24541
Virginia Oncology Care P.C.
Richlands, Virginia, United States, 24641
United States, Washington
Western Washington Medical Group
Everett, Washington, United States, 98201

Sponsors and Collaborators

Cell Therapeutics

Investigators

Study Chair:

Brenda Garrison

PPD, Incorporated

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000269907, CTI-PGT302, CWRU-CTI-1503
Study First Received:	February 5, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00054184 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent non-small cell lung cancer
stage IV non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Carcinoma
Docetaxel
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009