Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

CT-2103/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating stage IIIB, stage IV, or recurrent non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel plus carboplatin to that of paclitaxel plus carboplatin in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: carboplatin; Drug: paclitaxel; Drug: paclitaxel poliglumex

Detailed Description

OBJECTIVES:

• Compare the efficacy of polyglutamate paclitaxel (CT-2103) and carboplatin vs paclitaxel and carboplatin, in terms of duration of overall survival, in patients with stage IIIB or IV or recurrent non-small cell lung cancer who have a performance status of 2.
• Compare the disease control (percentage of patients with no disease progression for at least 12 weeks) and time to progression in patients treated with these regimens.
• Compare the response rate in patients with measurable disease treated with these regimens.
• Compare the improvement in lung cancer symptoms in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, disease stage (IV vs other), geographic location (US vs Western Europe and Canada vs the rest of the world), and prior brain metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive polyglutamate paclitaxel (CT-2103) IV over 10 minutes and carboplatin IV over 30 minutes on day 1.
• Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.

Treatment repeats in both arms every 21 days for 6 courses 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 370 patients (185 per treatment arm) will be accrued for this study within 13 months.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Hematology and Oncology Associates of Alabama
    • Hoover, Alabama, United States, 35216
      • Clinical Research Consultants, Inc
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Arizona Clinical Research Center
  • California
    • Encino, California, United States, 91316
      • Synergy Hematology/Oncology Medical Associates
    • Mission Hills, California, United States, 91345
      • Holy Cross Providence Cancer Center
    • Montebello, California, United States, 90640
      • Clinical Trials and Research Associates, Incorporated
    • Torrance, California, United States, 90505
      • California Hematology/Oncology Medical Group
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • Hematology Oncology, P.C.
  • Florida
    • Hudson, Florida, United States, 34667
      • New Hope Cancer Centers
    • Melbourne, Florida, United States, 32901
      • Omni Healthcare, PA
    • Ormond Beach, Florida, United States, 32174
      • Metcare Oncology
    • Port Saint Lucie, Florida, United States, 34952
      • Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers, P.C.
    • Tucker, Georgia, United States, 30084
      • Georgia Cancer Specialists - Tucker
  • Illinois
    • Joliet, Illinois, United States, 60432
      • Silver Cross Hospital
    • Skokie, Illinois, United States, 60077
      • Gross Point Medical Center
  • Kentucky
    • Pikeville, Kentucky, United States, 41501
      • Kentucky Cancer Clinic
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic, P.A.
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Columbia Comprehensive Cancer Care Clinic
    • Rolla, Missouri, United States, 65401
      • Bond Clinic
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Las Vegas Cancer Center
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Summit Medical Group, P.A.
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center - Canton Office
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Oncology, Inc. - St. John Campus
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Charleston Cancer Center
    • Sumter, South Carolina, United States, 29150
      • Santee Hematology Oncology
  • Tennessee
    • Clarksville, Tennessee, United States, 37043
      • Clarksville Regional Hematology/Oncology Group
    • Collierville, Tennessee, United States, 38017
      • Family Cancer Center
  • Texas
    • Houston, Texas, United States, 77030-4009
      • University of Texas - MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • Cancer Therapy and Research Center
  • Virginia
    • Richlands, Virginia, United States, 24641
      • Virginia Oncology Care P.C.
  • Washington
    • Burien, Washington, United States, 98166
      • Highline Medical Oncology
    • Puyallup, Washington, United States, 98372
      • Rainier Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

  • Locally advanced or recurrent disease previously treated with radiotherapy and/or surgery
  • Stage IIIB and not a candidate for combined modality therapy
  • Stage IV
• No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology

• Cytological diagnosis must be based on the following:

  • No cellular diagnosis by sputum cytology alone
  • Cytologic specimens obtained from brushings, washings, or needle aspiration of a defined lesion or pleural effusion are acceptable
• Measurable or nonmeasurable disease

• 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:

  • Neurologic function stable for 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 2

Life expectancy

• Not specified

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)
• SGOT/SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
• Alkaline phosphatase no greater than 2.5 times ULN (except for laboratory documentation that demonstrates bone origin)

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• No unstable angina
• No myocardial infarction within the past 6 months
• Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for at least 6 months prior to study entry

Neurologic

• See Disease Characteristics
• No neuropathy greater than grade 1
• No evidence of unstable neurological symptoms within the past 4 weeks (2 weeks for neurological symptoms due to brain metastases)

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid, poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide)
• No clinically significant active infection
• No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin cancer
• No other unstable medical conditions
• No circumstance that would preclude study completion or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior systemic biologic agent for lung cancer

Chemotherapy

• See Disease Characteristics
• No prior systemic therapy for lung cancer including radiosensitizing agents

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• Recovered from prior major surgery

Other

• More than 12 weeks since prior participation in any research study or treatment with investigational drugs
• Recovered from prior investigational therapy or stable for 4 weeks before study treatment
• No other concurrent investigational drugs
• No other concurrent systemic antitumor therapy
• No concurrent amifostine
• Concurrent bisphosphonates allowed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Masking: NONE

Collaborators and Investigators

• Sponsor: CTI BioPharma
• Investigators: Study Chair: Melinda Bomar, PPD, Incorporated

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2003
• Primary Completion (ACTUAL): October 1, 2004
• Study Completion (ACTUAL): October 1, 2004

Study Registration Dates

• First Submitted: February 5, 2003
• First Submitted That Met QC Criteria: February 5, 2003
• First Posted (ESTIMATE): February 6, 2003

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Albumin-Bound Paclitaxel; Paclitaxel poliglumex
• Other Study ID Numbers: CTI-PGT303; CDR0000269910 (REGISTRY: PDQ (Physician Data Query))