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

NCT00054184 | Terminated Phase 3

• 3 other identifiers: CTI-PGT302CDR0000269907CWRU-CTI-1503
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 35

Brief 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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Saftey

  Baseline to end of treatment

Secondary Outcomes (1)

• Efficacy

  Basline to EOS

Study Arms (1)

Study drug

EXPERIMENTAL

Drug: docetaxel; Drug: paclitaxel poliglumex

Interventions

docetaxel DRUG

Study drug

paclitaxel poliglumex DRUG

Study drug

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• CTI BioPharma: lead

Study Sites (35)

Clinical Research Consultants, Incorporated

Hoover, Alabama, 35216, United States

Location

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Highlands Oncology Group - Springdale

Springdale, Arkansas, 72764, United States

Location

Pacific Cancer Medical Center, Incorporated

Anaheim, California, 92801, United States

Location

Synergy Hematology/Oncology Medical Associates

Encino, California, 91316, United States

Location

California Cancer Care, Inc.

Greenbrae, California, 94904-2007, United States

Location

California Hematology/Oncology Medical Group

Torrance, California, 90505, United States

Location

Northwest Oncology and Hematology Associates

Coral Springs, Florida, 33065, United States

Location

Florida Oncology Associates

Jacksonville, Florida, 32207, United States

Location

Hematology Oncology Associates of theTreasure Coast - Port St. Lucie

Port Saint Lucie, Florida, 34952, United States

Location

Suburban Hematology-Oncology

Snellville, Georgia, 30078-6782, United States

Location

Gross Point Medical Center

Skokie, Illinois, 60077, United States

Location

Western Kentucky Hematology/Oncology Group

Paducah, Kentucky, 42003, United States

Location

Kentucky Cancer Clinic

Pikeville, Kentucky, 41501, United States

Location

Saint Joseph Oncology, Incorporated

Saint Joseph, Missouri, 64507, United States

Location

Montana Cancer Specialists

Missoula, Montana, 59807-7877, United States

Location

Las Vegas Cancer Center

Las Vegas, Nevada, 89102, United States

Location

Unknown Facility

Howell Township, New Jersey, 07731, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

New Mexico Oncology-Hematology Consultants, Limited

Albuquerque, New Mexico, 87109, United States

Location

Queens Medical Associates, PC

Fresh Meadows, New York, 11365, United States

Location

Piedmont Oncology Specialist, II, PLLC

Monroe, North Carolina, 28110, United States

Location

Odyssey Research Services

Bismarck, North Dakota, 58501, United States

Location

Gabrail Cancer Center - Canton Office

Canton, Ohio, 44718, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

Charleston Hematology-Oncology, P.A.

Charleston, South Carolina, 29403, United States

Location

Tri County Oncology Associates

Rock Hill, South Carolina, 29732-1119, United States

Location

Santee Hematology Oncology

Sumter, South Carolina, 29150, United States

Location

Family Cancer Center

Collierville, Tennessee, 38017, United States

Location

Southwest Regional Cancer Center

Austin, Texas, 78705, United States

Location

Unknown Facility

Richardson, Texas, 75080, United States

Location

Danville Hematology and Oncology, Incorporated

Danville, Virginia, 24541, United States

Location

Virginia Oncology Care P.C.

Richlands, Virginia, 24641, United States

Location

Western Washington Medical Group

Everett, Washington, 98201, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; paclitaxel poliglumex

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Brenda Garrison

  PPD, Incorporated

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: January 1, 2003
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

US (35)