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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
Open (Enrolling)
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


- 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

- 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

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


- Histologically confirmed non-small cell lung cancer (NSCLC)

- Documented clinical or radiologic disease progression on or after initial systemic

- 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

- 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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Al least 16 weeks


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- 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


- Creatinine no greater than 1.5 times ULN


- 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


- 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

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


Biologic therapy

- Not specified


- See Disease Characteristics

- No prior polyglutamate paclitaxel

- No prior docetaxel

Endocrine therapy

- See Disease Characteristics


- See Disease Characteristics

- No concurrent radiotherapy


- See Disease Characteristics

- Recovered from prior major surgery


- 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:


Study Design:

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

Principal Investigator

Brenda Garrison

Investigator Role:

Study Chair

Investigator Affiliation:

PPD, Incorporated


United States: Federal Government

Study ID:




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



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