Clinical trial NCT00054184: Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
Official title: CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer (NSCLC): A Phase III Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage IV non-small cell lung cancer
stage IIIB non-small cell lung cancer
Lead sponsor: CTI BioPharma
Sponsor class: INDUSTRY
First posted: 2003-02-06
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Saftey
timeFrame: Baseline to end of treatment
Secondary outcomes:
measure: Efficacy
timeFrame: Basline to EOS
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Clinical Research Consultants, Incorporated
state: Alabama
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group - Springdale
state: Arkansas
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Incorporated
state: California
city: Encino
country: United States
facility: Synergy Hematology/Oncology Medical Associates
state: California
city: Greenbrae
country: United States
facility: California Cancer Care, Inc.
state: California
city: Torrance
country: United States
facility: California Hematology/Oncology Medical Group
state: California
city: Coral Springs
country: United States
facility: Northwest Oncology and Hematology Associates
state: Florida
city: Jacksonville
country: United States
facility: Florida Oncology Associates
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
state: Florida
city: Snellville
country: United States
facility: Suburban Hematology-Oncology
state: Georgia
city: Skokie
country: United States
facility: Gross Point Medical Center
state: Illinois
city: Paducah
country: United States
facility: Western Kentucky Hematology/Oncology Group
state: Kentucky
city: Pikeville
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Saint Joseph
country: United States
facility: Saint Joseph Oncology, Incorporated
state: Missouri
city: Missoula
country: United States
facility: Montana Cancer Specialists
state: Montana
city: Las Vegas
country: United States
facility: Las Vegas Cancer Center
state: Nevada
city: Howell
country: United States
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Oncology-Hematology Consultants, Limited
state: New Mexico
city: Fresh Meadows
country: United States
facility: Queens Medical Associates, PC
state: New York
city: Monroe
country: United States
facility: Piedmont Oncology Specialist, II, PLLC
state: North Carolina
city: Bismarck
country: United States
facility: Odyssey Research Services
state: North Dakota
city: Canton
country: United States
facility: Gabrail Cancer Center - Canton Office
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Pennsylvania Oncology Hematology Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology-Oncology, P.A.
state: South Carolina
city: Rock Hill
country: United States
facility: Tri County Oncology Associates
state: South Carolina
city: Sumter
country: United States
facility: Santee Hematology Oncology
state: South Carolina
city: Collierville
country: United States
facility: Family Cancer Center
state: Tennessee
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Richardson
country: United States
state: Texas
city: Danville
country: United States
facility: Danville Hematology and Oncology, Incorporated
state: Virginia
city: Richlands
country: United States
facility: Virginia Oncology Care P.C.
state: Virginia
city: Everett
country: United States
facility: Western Washington Medical Group
state: Washington
Study officials:
affiliation: PPD, Incorporated
name: Brenda Garrison
role: STUDY_CHAIR
References: