Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Pharmaceutical / Industry	CTI-PGT302 CWRU-CTI-1503, NCT00054184

Objectives

1. 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.
2. Compare the safety and toxicity of these regimens in these patients.
3. 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.
4. Compare the improvement in lung cancer symptoms in patients treated with these regimens.
5. Compare the frequency of grade 3 and 4 neurotoxicity, edema, alopecia, and side effects related to corticosteroids in patients treated with these regimens.
6. Determine the percentage of patients who receive at least 4 courses of study treatment.
7. Compare the response rate in patients with measurable disease treated with these regimens.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 840 patients (420 per treatment arm) will be accrued for this study within 18 months.

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.

Trial Contact Information

Trial Lead Organizations

Cell Therapeutics, Incorporated

Brenda Garrison, Protocol chair		Ph: 910-772-6952

Registry Information
Official Title		CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer (NSCLC): A Phase III Study
Trial Start Date		2003-01-15
Registered in ClinicalTrials.gov		NCT00054184
Date Submitted to PDQ		2002-12-23
Information Last Verified		2004-07-26
NCI Grant/Contract Number		CA43703

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