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

Primary Purpose

NSCLC

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CT-2103/carboplatin
paclitaxel/carboplatin
Sponsored by
CTI BioPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC focused on measuring NSCLC, women, CT-2103, paclitaxel, carboplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Scottsdale Medical Specialists
  • Mayo Clinic
  • Hembree Regional Cancer Center
  • Providence St. Joseph Medical Center
  • Southwest Cancer Care
  • Clinical Trials & Research Institute
  • Stanford Cancer Center
  • Hartford Hospital
  • Broward Oncology Associates
  • Horizon Institute for Clinical Research
  • Memorial Cancer Institute
  • Pasco Pinellas Cancer Center
  • Joliet Oncology Hematology Associates, Ltd
  • Loyola University
  • Hematology Oncology Consultants
  • Cancer Care Center
  • Providence Medical Group
  • Family Medicine of Vincennes Clinical Trials Center
  • Kansas City Cancer Center
  • Henry Ford Health System, Josephine Ford Cancer Center
  • W. Michigan Regional Cancer & Blood Center
  • Hattiesburg Clinic
  • Columbia Comprehensive Cancer Care Clinics
  • St. Louis University
  • Las Vegas Cancer Center
  • VA Sierra Nevada Health Care System
  • Lincoln Medical and Mental Health Center
  • Arena Oncology Associates
  • Richmond University Medical Center
  • New York Medical College
  • St Alexius Medical Center
  • Blood and Cancer Center
  • Aultman Hospital Clinical Trials
  • UIMA, Inc / University of Cincinnati-Barrett Cancer Center
  • University of Oklahoma Health Science Center
  • Vita Hematology Oncology, P.C.
  • The Family Cancer Center
  • Mid-South Cancer Center
  • Southwest Regional Cancer Center
  • Lone Star Oncology Consultants
  • Mary Crowley Medical Research Center
  • Northern Utah Associates
  • Cancer Outreach Associates, LLC
  • Virginia Mason Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety

Full Information

First Posted
December 17, 2007
Last Updated
October 14, 2020
Sponsor
CTI BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT00576225
Brief Title
CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Study Start Date
September 2007 (Actual)
Primary Completion Date
April 5, 2010 (Actual)
Study Completion Date
April 5, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CTI BioPharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC
Keywords
NSCLC, women, CT-2103, paclitaxel, carboplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CT-2103/carboplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
paclitaxel/carboplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival
Time Frame
up to 3 years post treatment
Secondary Outcome Measure Information:
Title
progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety
Time Frame
up to 3 years post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with baseline estradiol >25 pg/mL Histologically- or cytologically-confirmed diagnosis of NSCLC. ECOG performance score (PS) of 0, 1, or 2. 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. At least 18 years of age. Adequate bone marrow function Adequate renal function Adequate hepatic function Life expectancy ≥12 weeks Exclusion Criteria: Known hypersensitivity to the excipients or the study drug (either CT-2103, paclitaxel, or carboplatin that the patient will receive. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology. Weight loss >10% in previous 6 months LDH > 2.5X IULN Both LDH > 1.5X IULN and ≥ 5% weight loss in previous 6 months BMI >35 Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent. Local palliative radiotherapy < 7 days before randomization. Radiation with curative intent < 30 days before randomization. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer. Grade 2 or greater neuropathy. Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization. Clinically significant active infection for which active therapy is underway. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent. Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization. Pregnant women or nursing mothers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack W. Singer, M.D.
Organizational Affiliation
CTI BioPharma
Official's Role
Study Director
Facility Information:
Facility Name
Scottsdale Medical Specialists
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Hembree Regional Cancer Center
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72903
Country
United States
Facility Name
Providence St. Joseph Medical Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Southwest Cancer Care
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Clinical Trials & Research Institute
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Broward Oncology Associates
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Horizon Institute for Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Memorial Cancer Institute
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Pasco Pinellas Cancer Center
City
Tarpon Springs
State/Province
Florida
ZIP/Postal Code
34691
Country
United States
Facility Name
Joliet Oncology Hematology Associates, Ltd
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Loyola University
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Hematology Oncology Consultants
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Cancer Care Center
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Providence Medical Group
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Family Medicine of Vincennes Clinical Trials Center
City
Vincennes
State/Province
Indiana
ZIP/Postal Code
47591
Country
United States
Facility Name
Kansas City Cancer Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Henry Ford Health System, Josephine Ford Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
W. Michigan Regional Cancer & Blood Center
City
Free Soil
State/Province
Michigan
ZIP/Postal Code
49411
Country
United States
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Columbia Comprehensive Cancer Care Clinics
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
St. Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Las Vegas Cancer Center
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
VA Sierra Nevada Health Care System
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Lincoln Medical and Mental Health Center
City
New York
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
Arena Oncology Associates
City
New York
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Richmond University Medical Center
City
Staten Island
State/Province
New York
ZIP/Postal Code
10310
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
St Alexius Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Blood and Cancer Center
City
Canfield
State/Province
Ohio
ZIP/Postal Code
44406
Country
United States
Facility Name
Aultman Hospital Clinical Trials
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
UIMA, Inc / University of Cincinnati-Barrett Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
Facility Name
Vita Hematology Oncology, P.C.
City
Fountain Hill
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
The Family Cancer Center
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
Mid-South Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Southwest Regional Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Lone Star Oncology Consultants
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Northern Utah Associates
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Cancer Outreach Associates, LLC
City
Arlington
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98111
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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