Carboplatin With Either Paclitaxel Poliglumex or Paclitaxel in Treating Women With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

October 2, 2020 updated by: CTI BioPharma

Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol >30 pg/mL

RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, and paclitaxel poliglumex, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving carboplatin together with paclitaxel poliglumex is more effective than giving carboplatin together with paclitaxel in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel poliglumex to see how well they work compared with carboplatin and paclitaxel in treating women with stage III, stage IV, or recurrent non-small cell lung cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Compare the overall survival of patients with chemotherapy-naïve stage IIIB or IV or recurrent non-small cell lung cancer treated with paclitaxel poliglumex and carboplatin vs paclitaxel and carboplatin.

Secondary

  • Compare the progression-free survival of women treated with these regimens.
  • Compare the disease control in women treated with these regimens.
  • Compare the clinical benefit in women treated with these regimens.
  • Compare the response rate in women treated with these regimens.
  • Compare the quality of life of women treated with these regimens.
  • Compare the safety and tolerability in women treated with these regimens.

OUTLINE: This is a multicenter study.

Patients are stratified according to age (≥ 60 vs < 60 years old), geographical location (United States of America, Canada, or Australia vs the rest of the world), extent of disease (independent of brain metastases, i.e., brain metastases are not considered in determining extent of disease) (intrathoracic disease only vs extrathoracic disease), and ECOG performance status (0 or 1 vs 2). Patients will be randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive paclitaxel poliglumex IV over 10 minutes followed by carboplatin IV over 30 minutes on day 1.
  • Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each course, and at the completion of study treatment by the Pain Assessment Patient Questionnaire, the Pulmonary Symptom Index, and the Functional Assessment of Cancer Therapy- Lung Cancer Subscale (FACT-LCS) (only in countries in which a validated translation is currently available).

After completion of study therapy, patients are followed at least monthly.

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Medical Specialists
    • California
      • Burbank, California, United States, 91505
        • Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
      • Escondido, California, United States, 92025-4404
        • Southwest Cancer Care - Escondido
      • Montebello, California, United States, 90640
        • Clinical Trials and Research Associates, Incorporated
      • Stanford, California, United States, 94305-5824
        • Stanford Cancer Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33308-1414
        • Broward Oncology Associates
      • Hollywood, Florida, United States, 33021
        • Horizon Institute for Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Cancer Institute at Rush University Medical Center
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Naperville, Illinois, United States, 60565
        • Hematology Oncology Consultants - Naperville
      • Olympia Fields, Illinois, United States, 60461
        • Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Cancer Center of Indiana
      • Terre Haute, Indiana, United States, 47802
        • Providence Medical Group
      • Vincennes, Indiana, United States, 47591
        • Family Medicine of Vincennes Clinical Trial Center
    • Michigan
      • Free Soil, Michigan, United States, 49411
        • West Michigan Regional Cancer and Blood Center
      • Southfield, Michigan, United States, 48275
        • Newland Medical Associates PC - Southfield
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic, PA at Forrest General
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Columbia Comprehensive Cancer Care Clinic
      • Kansas City, Missouri, United States, 64131
        • Kansas City Cancer Centers - South
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University Cancer Center
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Las Vegas Cancer Center
      • Reno, Nevada, United States, 89520
        • Veterans Affairs Medical Center - Reno
    • New York
      • Bronx, New York, United States, 10451
        • Lincoln Medical and Mental Health Center
      • Staten Island, New York, United States, 10310-1699
        • Richmond University Medical Center
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic, PC
    • Ohio
      • Canfield, Ohio, United States, 44406
        • Blood and Cancer Center, Incorporated
      • Canton, Ohio, United States, 44710-1799
        • Aultman Cancer Center at Aultman Hospital
      • Cincinnati, Ohio, United States, 45219
        • Charles M. Barrett Cancer Center at University Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Cancer Institute
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Vita Hematology Oncology at St. Luke's Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Cancer Centers of the Carolinas - Eastside
    • Tennessee
      • Collierville, Tennessee, United States, 38077
        • Family Cancer Center, PLLC - Collierville
      • Germantown, Tennessee, United States, 38138
        • Mid-South Cancer Center
    • Texas
      • Austin, Texas, United States, 78705
        • Southwest Regional Cancer Center - Central
      • Austin, Texas, United States, 78759
        • Lone Star Oncology - Austin
      • Dallas, Texas, United States, 75246
        • Mary Crowley Medical Research Center at Sammons Cancer Center
    • Utah
      • Ogden, Utah, United States, 84403
        • Utah Hematology Oncology, PC
    • Virginia
      • Abingdon, Virginia, United States, 24211
        • Cancer Outreach Associates - Abingdon
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98119
        • Cell Therapeutics, Incorporated

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 118 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)

    • Cytologic specimens obtained by brushings, washings, or needle aspiration of a defined lesion or from a pleural effusion are acceptable; sputum cytology alone is not acceptable for determining cell type

  • Must meet one of the following criteria:

    • Recurrent disease following completion of radiation or surgery
    • Stage IIIB disease and not a candidate for combined modality therapy (primary radiation therapy or surgery)
    • Stage IV disease
  • Patients may have either measurable or nonmeasurable disease according to RECIST criteria

  • Baseline estradiol > 30 pg/mL

    • Patients on hormone replacement therapy are eligible provided baseline estradiol > 30 pg/mL

  • Patients with known brain metastases must have received standard antitumor treatment (e.g. whole brain radiation, stereotactic radioablation, or surgery) for their CNS metastases as defined by the site's institutional standards

    • Neurologic function must have been stable for 2 weeks before randomization and patients must either be off steroid therapy for their brain metastases or on a tapering regimen
    • Patients must have recovered from therapy for their brain metastases with no evidence of significant unstable neurological symptoms within the 4 weeks before study randomization
  • No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology

PATIENT CHARACTERISTICS:

  • Female
  • ECOG performance score 0-2
  • Life expectancy ≥ 12 weeks
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL (may be achieved with transfusion)
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 times ULN (CTC grade 1) (patients with Gilbert syndrome or other hereditary bilirubin defects may be included regardless of bilirubin levels)
  • SGOT and SGPT ≤ 2.5 times ULN (CTC grade 0 or 1) (5 times ULN [CTC grade 0 to 2] if due to liver metastases)
  • Alkaline phosphatase ≤ 2.5 times ULN except for elevated alkaline phosphatase with laboratory documentation that demonstrates bone origin
  • No pregnant women or nursing mothers
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation
  • No known hypersensitivity to study drugs or excipients

  • Meets all of the following criteria:

    • No weight loss > 10% in previous 6 months
    • Lactate dehydrogenase (LDH) ≤ 600 IU/L (central laboratory) regardless of weight loss
    • LDH ≤ 400 IU/L (central laboratory) and no weight loss ≥ 5% in previous 6 months
    • BMI ≤ 35
  • No concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer
  • No neuropathy grade 2 or greater
  • No clinically significant active infection for which active therapy is underway

  • No unstable medical conditions including unstable angina or myocardial infarction within the past 6 months

    • Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable
  • No circumstance that would preclude completion of the study or the required follow-up

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from major surgery
  • At least 7 days since prior local palliative radiotherapy
  • At least 30 days since prior radiation therapy with curative intent
  • At least 4 weeks since prior investigational therapy, unless local requirements are more stringent
  • No prior systemic chemotherapy for the treatment of lung cancer, including systemic radiosensitizers used to treat brain metastases or any biologic agents
  • No concurrent non-protocol-specified systemic antitumor therapy
  • No concurrent amifostine, investigational agents, other cytotoxic agents for this disease

  • No concurrent radiotherapy (with the exception of radiotherapy for brain or bone metastases for palliative purposes or radiotherapy for a condition other than NSCLC that was ongoing at the time of randomization)

    • Patients receiving palliative radiotherapy (treatment for symptomatic metastatic disease) may be treated while on study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive paclitaxel poliglumex IV over 10 minutes followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: carboplatin
Given IV
Drug: paclitaxel poliglumex
Given IV
Active Comparator: Arm II
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: paclitaxel
Given IV
Drug: carboplatin
Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Disease control
Clinical benefit as defined by use of opiates, growth factors, and transfusions,
Response rate as assessed by complete response or partial response per RECIST criteria
Quality of life as assessed by Fact-LCS Scores and Pulmonary Symptom Index (PSI) Scores and Pain Scores
Safety as assessed by NCI CTCAE Version 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CTI BioPharma

Investigators

  • Study Chair: Fred B. Oldham, MD, CTI BioPharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2007

Primary Completion (Actual)

December 25, 2007

Study Completion (Actual)

December 25, 2007

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 30, 2007

First Posted (Estimate)

October 31, 2007

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTI-PGT-07-00400
  • CDR0000573340 (Registry Identifier: PDQ (Physician Data Query))
  • EUDRACT-2007-004167-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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