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

Sponsor

CTI BioPharma (Industry)

Overall Status

Terminated

CT.gov ID

NCT00054184

Collaborator

(none)

350

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: docetaxel Drug: paclitaxel poliglumex	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer (NSCLC): A Phase III Study

Actual Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Oct 1, 2004

Actual Study Completion Date :

Oct 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study drug	Drug: docetaxel Drug: paclitaxel poliglumex

Arm

Intervention/Treatment

Experimental: Study drug

Drug: docetaxel

Drug: paclitaxel poliglumex

Outcome Measures

Primary Outcome Measures

Saftey [Baseline to end of treatment]

Secondary Outcome Measures

Efficacy [Basline to EOS]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Consultants, Incorporated	Hoover	Alabama	United States	35216
2	Arizona Clinical Research Center	Tucson	Arizona	United States	85712
3	Highlands Oncology Group - Springdale	Springdale	Arkansas	United States	72764
4	Pacific Cancer Medical Center, Incorporated	Anaheim	California	United States	92801
5	Synergy Hematology/Oncology Medical Associates	Encino	California	United States	91316
6	California Cancer Care, Inc.	Greenbrae	California	United States	94904-2007
7	California Hematology/Oncology Medical Group	Torrance	California	United States	90505
8	Northwest Oncology and Hematology Associates	Coral Springs	Florida	United States	33065
9	Florida Oncology Associates	Jacksonville	Florida	United States	32207
10	Hematology Oncology Associates of theTreasure Coast - Port St. Lucie	Port Saint Lucie	Florida	United States	34952
11	Suburban Hematology-Oncology	Snellville	Georgia	United States	30078-6782
12	Gross Point Medical Center	Skokie	Illinois	United States	60077
13	Western Kentucky Hematology/Oncology Group	Paducah	Kentucky	United States	42003
14	Kentucky Cancer Clinic	Pikeville	Kentucky	United States	41501
15	Saint Joseph Oncology, Incorporated	Saint Joseph	Missouri	United States	64507
16	Montana Cancer Specialists	Missoula	Montana	United States	59807-7877
17	Las Vegas Cancer Center	Las Vegas	Nevada	United States	89102
18		Howell	New Jersey	United States	07731
19	Morristown Memorial Hospital	Morristown	New Jersey	United States	07962
20	New Mexico Oncology-Hematology Consultants, Limited	Albuquerque	New Mexico	United States	87109
21	Queens Medical Associates, PC	Fresh Meadows	New York	United States	11365
22	Piedmont Oncology Specialist, II, PLLC	Monroe	North Carolina	United States	28110
23	Odyssey Research Services	Bismarck	North Dakota	United States	58501
24	Gabrail Cancer Center - Canton Office	Canton	Ohio	United States	44718
25	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
26	Pennsylvania Oncology Hematology Associates	Philadelphia	Pennsylvania	United States	19106
27	Charleston Hematology-Oncology, P.A.	Charleston	South Carolina	United States	29403
28	Tri County Oncology Associates	Rock Hill	South Carolina	United States	29732-1119
29	Santee Hematology Oncology	Sumter	South Carolina	United States	29150
30	Family Cancer Center	Collierville	Tennessee	United States	38017
31	Southwest Regional Cancer Center	Austin	Texas	United States	78705
32		Richardson	Texas	United States	75080
33	Danville Hematology and Oncology, Incorporated	Danville	Virginia	United States	24541
34	Virginia Oncology Care P.C.	Richlands	Virginia	United States	24641
35	Western Washington Medical Group	Everett	Washington	United States	98201