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

Launched by CTI BIOPHARMA · Feb 5, 2003

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility 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