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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Brenda Garrison

Investigator Role:

Study Chair

Investigator Affiliation:

PPD, Incorporated

Authority:

United States: Federal Government

Study ID:

CDR0000269907

NCT ID:

NCT00054184

Start Date:

January 2003

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Ireland Cancer CenterCleveland, Ohio  44106-5065
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Southwest Regional Cancer CenterAustin, Texas  78705
California Cancer Care, Inc.Greenbrae, California  94904-2007
Saint Joseph Oncology, IncorporatedSaint Joseph, Missouri  64507
Arizona Clinical Research CenterTucson, Arizona  85712
New Mexico Oncology-Hematology Consultants, LimitedAlbuquerque, New Mexico  87109
Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107
Danville Hematology and Oncology, IncorporatedDanville, Virginia  24541
Highlands Oncology Group - SpringdaleSpringdale, Arkansas  72764
Florida Oncology AssociatesOrange Park, Florida  32073
Charleston Hematology-Oncology, P.A.Charleston, South Carolina  29403
Austin, Texas  78705
California Hematology/Oncology Medical GroupTorrance, California  90505
Queens Medical Associates, PCFresh Meadows, New York  11365
Santee Hematology OncologySumter, South Carolina  29150
Family Cancer CenterCollierville, Tennessee  38017
Hackensack, New Jersey  07601
Northwest Oncology and Hematology AssociatesCoral Springs, Florida  33065
Hematology Oncology Associates of theTreasure Coast - Port St. LuciePort Saint Lucie, Florida  34952
Odyssey Research ServicesBismarck, North Dakota  58501
Clinical Research Consultants, IncorporatedHoover, Alabama  35216
Pacific Cancer Medical Center, IncorporatedAnaheim, California  92801
Synergy Hematology/Oncology Medical AssociatesEncino, California  91316
Suburban Hematology-OncologySnellville, Georgia  30078-6782
Gross Point Medical CenterSkokie, Illinois  60077
Western Kentucky Hematology/Oncology GroupPaducah, Kentucky  42003
Kentucky Cancer ClinicPikeville, Kentucky  41501
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Las Vegas Cancer CenterLas Vegas, Nevada  89102
Piedmont Oncology Specialist, II, PLLCMonroe, North Carolina  28110
Gabrail Cancer Center - Canton OfficeCanton, Ohio  44718
Tri County Oncology AssociatesRock Hill, South Carolina  29732-1119
Virginia Oncology Care P.C.Richlands, Virginia  24641
Western Washington Medical GroupEverett, Washington  98201