CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL

October 14, 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 > 25 pg/mL

This study is designed to test whether CT-2103/carboplatin provides improved overall survival compared to paclitaxel/carboplatin in women with NSCLC who have estradiol levels >30 pg/ml.

Study Overview

Status

Withdrawn

Conditions

Study Type

Interventional

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

    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Medical Specialists
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Hembree Regional Cancer Center
    • California
      • Burbank, California, United States, 91505
        • Providence St. Joseph Medical Center
      • Escondido, California, United States, 92025
        • Southwest Cancer Care
      • Montebello, California, United States, 90640
        • Clinical Trials & Research Institute
      • Stanford, California, United States, 94305
        • Stanford Cancer Center
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Broward Oncology Associates
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute
      • Hollywood, Florida, United States, 33021
        • Horizon Institute for Clinical Research
      • Tarpon Springs, Florida, United States, 34691
        • Pasco Pinellas Cancer Center
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology hematology Associates, Ltd
      • Maywood, Illinois, United States, 60153
        • Loyola University
      • Naperville, Illinois, United States, 60540
        • Hematology Oncology Consultants
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Cancer Care Center
      • Terre Haute, Indiana, United States, 47802
        • Providence Medical Group
      • Vincennes, Indiana, United States, 47591
        • Family Medicine of Vincennes Clinical Trials Center
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Kansas City Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System, Josephine Ford Cancer Center
      • Free Soil, Michigan, United States, 49411
        • W. Michigan Regional Cancer & Blood Center
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Columbia Comprehensive Cancer Care Clinics
      • Saint Louis, Missouri, United States, 63110
        • St. Louis University
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Las Vegas Cancer Center
      • Reno, Nevada, United States, 89502
        • VA Sierra Nevada Health Care System
    • New York
      • New York, New York, United States, 10451
        • Lincoln Medical and Mental Health Center
      • New York, New York, United States, 11042
        • Arena Oncology Associates
      • Staten Island, New York, United States, 10310
        • Richmond University Medical Center
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • St Alexius Medical Center
    • Ohio
      • Canfield, Ohio, United States, 44406
        • Blood and Cancer Center
      • Canton, Ohio, United States, 44710
        • Aultman Hospital Clinical Trials
      • Cincinnati, Ohio, United States, 45267
        • UIMA, Inc / University of Cincinnati-Barrett Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • University of Oklahoma Health Science Center
    • Pennsylvania
      • Fountain Hill, Pennsylvania, United States, 18105
        • Vita Hematology Oncology, P.C.
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • The Family Cancer Center
      • Germantown, Tennessee, United States, 38138
        • Mid-South Cancer Center
    • Texas
      • Austin, Texas, United States, 78759
        • Lone Star Oncology Consultants
      • Austin, Texas, United States, 78705
        • Southwest Regional Cancer Center
      • Dallas, Texas, United States, 75246
        • Mary Crowley Medical Research Center
    • Utah
      • Ogden, Utah, United States, 84403
        • Northern Utah Associates
    • Virginia
      • Arlington, Virginia, United States, 24211
        • Cancer Outreach Associates, LLC
    • Washington
      • Seattle, Washington, United States, 98111
        • Virginia Mason Medical Center

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women with baseline estradiol >25 pg/mL
  2. Histologically- or cytologically-confirmed diagnosis of NSCLC.
  3. ECOG performance score (PS) of 0, 1, or 2.
  4. Patients must meet one of the following criteria have either (1) Recurrent disease following completion of radiation or surgery, (2) Stage IIIB disease and not be a candidate for combined modality therapy (primary radiation therapy or surgery), or (3) Stage IV disease.
  5. At least 18 years of age.
  6. Adequate bone marrow function
  7. Adequate renal function
  8. Adequate hepatic function
  9. Life expectancy ≥12 weeks

Exclusion Criteria:

  1. Known hypersensitivity to the excipients or the study drug (either CT-2103, paclitaxel, or carboplatin that the patient will receive.
  2. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology.
  3. Weight loss >10% in previous 6 months
  4. LDH > 2.5X IULN
  5. Both LDH > 1.5X IULN and ≥ 5% weight loss in previous 6 months
  6. BMI >35
  7. Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent.
  8. Local palliative radiotherapy < 7 days before randomization.
  9. Radiation with curative intent < 30 days before randomization.
  10. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer.
  11. Grade 2 or greater neuropathy.
  12. Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization.
  13. Clinically significant active infection for which active therapy is underway.
  14. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent.
  15. Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization.
  16. Pregnant women or nursing mothers.

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
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
Paclitaxel (175 mg/m2, 3 hr IV infusion) and carboplatin (AUC 6) (30 minute IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.
EXPERIMENTAL: Experimental
CT-2103 (175 mg/m2 10 min IV infusion) and carboplatin (AUC 6, 30 min IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: up to 3 years post treatment
up to 3 years post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety
Time Frame: up to 3 years post treatment
up to 3 years post treatment

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Jack W. Singer, M.D., CTI BioPharma

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)

September 1, 2007

Primary Completion (ACTUAL)

April 5, 2010

Study Completion (ACTUAL)

April 5, 2010

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (ESTIMATE)

December 19, 2007

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

October 1, 2020

More Information

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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