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CT-2103 vs Gemcitabine or Vinorelbine for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced 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 Gemcitabine or Vinorelbine for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study


OBJECTIVES:

- Compare the efficacy of polyglutamate paclitaxel (CT-2103) vs gemcitabine or
vinorelbine, in terms of duration of overall survival, in patients with stage IIIB or
IV or recurrent non-small cell lung cancer who have a performance status of 2.

- Compare the safety of these regimens in these patients.

- Compare the disease control (percentage of patients with no disease progression for at
least 12 weeks) and time to progression in patients treated with these regimens.

- Compare the response rate in patients with measurable disease treated with these
regimens.

- Compare the improvement in lung cancer symptoms in patients treated with these
regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to gender, disease stage (IV vs other), geographic location (US vs Western Europe
and Canada vs the rest of the world), and prior brain metastases (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
every 21 days.

- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 every 28
days OR vinorelbine IV over 6-10 minutes on days 1, 8, and 15 every 21 days.

Treatment repeats in both arms for up to 6 courses 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 370 patients (185 per treatment arm) will be accrued for this
study within 13 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting
1 of the following criteria:

- Locally advanced or recurrent disease previously treated with radiotherapy
and/or surgery

- Stage IIIB and not a candidate for combined modality therapy

- Stage IV

- No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell
histology

- Cytological diagnosis must be based on the following:

- No cellular diagnosis by sputum cytology alone

- Cytologic specimens obtained from brushings, washings, or needle aspiration of a
defined lesion or pleural effusion are acceptable

- Measurable or nonmeasurable disease

- 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:

- Neurologic function stable for 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 2

Life expectancy

- Not specified

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)

- SGOT/SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases present)

- Alkaline phosphatase no greater than 2.5 times ULN (except for laboratory
documentation that demonstrates bone origin)

Renal

- Creatinine no greater than 1.5 times ULN

Cardiovascular

- No unstable angina

- No myocardial infarction within the past 6 months

- Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed
provided cardiac status has been stable for at least 6 months prior to study entry

Neurologic

- See Disease Characteristics

- No neuropathy greater than grade 1

- No evidence of unstable neurologic symptoms within the past 4 weeks (2 weeks for
neurologic symptoms due to brain metastases)

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid,
poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide)

- No clinically significant active infection

- No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin
cancer

- No other unstable medical conditions

- No circumstance that would preclude study completion or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior systemic biologic agent for lung cancer

Chemotherapy

- See Disease Characteristics

- No prior systemic chemotherapy for lung cancer including radiosensitizing agents

Endocrine therapy

- See Disease Characteristics

Radiotherapy

- See Disease Characteristics

- No concurrent radiotherapy

Surgery

- See Disease Characteristics

- Recovered from prior major surgery

Other

- More than 12 weeks since prior participation in any research study or treatment with
investigational drugs

- Recovered from prior investigational therapy or stable for 4 weeks before study
treatment

- 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

Meghann Smith

Investigator Role:

Study Chair

Investigator Affiliation:

PPD, Incorporated

Authority:

United States: Federal Government

Study ID:

CDR0000269908

NCT ID:

NCT00054197

Start Date:

January 2003

Completion Date:

Related Keywords:

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

Name

Location

Midwest Cancer Research Group, IncorporatedSkokie, Illinois  60077
New York Oncology Hematology, P.C. - LathamLatham, New York  12110-0610
Charleston Hematology-Oncology, P.A.Charleston, South Carolina  29403
Medical Oncology/HematologyGilroy, California  95020
Northwest Oncology and Hematology AssociatesCoral Springs, Florida  33065
Western Washington Medical GroupEverett, Washington  98201
Cooper Green HospitalBirmingham, Alabama  35233
Medschool Associates NorthReno, Nevada  89502
Clinical Research ServicesBismarck, North Dakota  58501
Western Washington Oncology, IncorporatedOlympia, Washington  98502