CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL
- Conditions
- NSCLC
- Interventions
- Drug: CT-2103/carboplatinDrug: paclitaxel/carboplatin
- Registration Number
- NCT00576225
- Lead Sponsor
- CTI BioPharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental CT-2103/carboplatin - Control paclitaxel/carboplatin -
- Primary Outcome Measures
Name Time Method Survival up to 3 years post treatment
- Secondary Outcome Measures
Name Time Method progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety up to 3 years post treatment
Trial Locations
- Locations (44)
Memorial Cancer Institute
🇺🇸Hollywood, Florida, United States
Loyola University
🇺🇸Maywood, Illinois, United States
Mary Crowley Medical Research Center
🇺🇸Dallas, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
The Family Cancer Center
🇺🇸Collierville, Tennessee, United States
Broward Oncology Associates
🇺🇸Fort Lauderdale, Florida, United States
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
Hematology Oncology Consultants
🇺🇸Naperville, Illinois, United States
Scottsdale Medical Specialists
🇺🇸Scottsdale, Arizona, United States
Hembree Regional Cancer Center
🇺🇸Fort Smith, Arkansas, United States
Horizon Institute for Clinical Research
🇺🇸Hollywood, Florida, United States
Pasco Pinellas Cancer Center
🇺🇸Tarpon Springs, Florida, United States
Providence St. Joseph Medical Center
🇺🇸Burbank, California, United States
Clinical Trials & Research Institute
🇺🇸Montebello, California, United States
St Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
Southwest Cancer Care
🇺🇸Escondido, California, United States
Lincoln Medical and Mental Health Center
🇺🇸New York, New York, United States
W. Michigan Regional Cancer & Blood Center
🇺🇸Free Soil, Michigan, United States
Cancer Care Center
🇺🇸New Albany, Indiana, United States
Providence Medical Group
🇺🇸Terre Haute, Indiana, United States
Kansas City Cancer Center
🇺🇸Overland Park, Kansas, United States
Family Medicine of Vincennes Clinical Trials Center
🇺🇸Vincennes, Indiana, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Lone Star Oncology Consultants
🇺🇸Austin, Texas, United States
Columbia Comprehensive Cancer Care Clinics
🇺🇸Jefferson City, Missouri, United States
Las Vegas Cancer Center
🇺🇸Henderson, Nevada, United States
Richmond University Medical Center
🇺🇸Staten Island, New York, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Arena Oncology Associates
🇺🇸New York, New York, United States
Blood and Cancer Center
🇺🇸Canfield, Ohio, United States
Mid-South Cancer Center
🇺🇸Germantown, Tennessee, United States
Northern Utah Associates
🇺🇸Ogden, Utah, United States
St. Louis University
🇺🇸Saint Louis, Missouri, United States
Vita Hematology Oncology, P.C.
🇺🇸Fountain Hill, Pennsylvania, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States
Cancer Outreach Associates, LLC
🇺🇸Arlington, Virginia, United States
Henry Ford Health System, Josephine Ford Cancer Center
🇺🇸Detroit, Michigan, United States
UIMA, Inc / University of Cincinnati-Barrett Cancer Center
🇺🇸Cincinnati, Ohio, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
Joliet Oncology Hematology Associates, Ltd
🇺🇸Joliet, Illinois, United States
VA Sierra Nevada Health Care System
🇺🇸Reno, Nevada, United States
Aultman Hospital Clinical Trials
🇺🇸Canton, Ohio, United States