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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CTI BioPharma
ClinicalTrials.gov Identifier:
NCT00054184
First received: February 5, 2003
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: docetaxel
Drug: paclitaxel poliglumex
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer (NSCLC): A Phase III Study

Resource links provided by NLM:


Further study details as provided by CTI BioPharma:

Primary Outcome Measures:
  • Saftey [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: Basline to EOS ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: January 2003
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study drug Drug: docetaxel Drug: paclitaxel poliglumex

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054184

  Show 35 Study Locations
Sponsors and Collaborators
CTI BioPharma
Investigators
Study Chair: Brenda Garrison PPD, Incorporated
  More Information

Additional Information:
No publications provided

Responsible Party: CTI BioPharma
ClinicalTrials.gov Identifier: NCT00054184     History of Changes
Other Study ID Numbers: CTI-PGT302, CDR0000269907, CWRU-CTI-1503
Study First Received: February 5, 2003
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by CTI BioPharma:
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Docetaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014