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

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00054184
Enrollment
350
Registered
2003-02-06
Start date
2003-01-31
Completion date
2004-10-31
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer

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.

Interventions

DRUGdocetaxel

Sponsors

CTI BioPharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
SafteyBaseline to end of treatment

Secondary

MeasureTime frame
EfficacyBasline to EOS

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026