CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL
This trial is active, not recruiting.
|Start date||September 2007|
|End date||January 2014|
|Trial size||450 participants|
|Trial identifier||NCT00576225, PGT307|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Scottsdale, AZ||Scottsdale Medical Specialists||no longer recruiting|
|Scottsdale, AZ||Mayo Clinic||no longer recruiting|
|Fort Smith, AR||Hembree Regional Cancer Center||no longer recruiting|
|Burbank, CA||Providence St. Joseph Medical Center||no longer recruiting|
|Escondido, CA||Southwest Cancer Care||no longer recruiting|
|Montebello, CA||Clinical Trials & Research Institute||no longer recruiting|
|Stanford, CA||Stanford Cancer Center||no longer recruiting|
|Hartford, CT||Hartford Hospital||no longer recruiting|
|Ft. Lauderdale, FL||Broward Oncology Associates||no longer recruiting|
|Hollywood, FL||Horizon Institute for Clinical Research||no longer recruiting|
|Hollywood, FL||Memorial Cancer Institute||no longer recruiting|
|Tarpon Springs, FL||Pasco Pinellas Cancer Center||no longer recruiting|
|Joliet, IL||Joliet Oncology Hematology Associates, Ltd||no longer recruiting|
|Maywood, IL||Loyola University||no longer recruiting|
|Naperville, IL||Hematology Oncology Consultants||no longer recruiting|
|New Albany, IN||Cancer Care Center||no longer recruiting|
|Terre Haute, IN||Providence Medical Group||no longer recruiting|
|Vincennes, IN||Family Medicine of Vincennes Clinical Trials Center||no longer recruiting|
|Overland Park, KS||Kansas City Cancer Center||no longer recruiting|
|Detroit, MI||Henry Ford Health System, Josephine Ford Cancer Center||no longer recruiting|
|Freesoil, MI||W. Michigan Regional Cancer & Blood Center||no longer recruiting|
|Hattiesburg, MS||Hattiesburg Clinic||no longer recruiting|
|Jefferson City, MO||Columbia Comprehensive Cancer Care Clinics||no longer recruiting|
|St. Louis, MO||St. Louis University||no longer recruiting|
|Henderson, NV||Las Vegas Cancer Center||no longer recruiting|
|Reno, NV||VA Sierra Nevada Health Care System||no longer recruiting|
|New York, NY||Lincoln Medical and Mental Health Center||no longer recruiting|
|Staten Island, NY||Richmond University Medical Center||no longer recruiting|
|Success, NY||Arena Oncology Associates||no longer recruiting|
|Valhalla, NY||New York Medical College||no longer recruiting|
|Bismark, NC||St Alexius Medical Center||no longer recruiting|
|Canfield, OH||Blood and Cancer Center||no longer recruiting|
|Canton, OH||Aultman Hospital Clinical Trials||no longer recruiting|
|Cincinnati, OH||UIMA, Inc / University of Cincinnati-Barrett Cancer Center||no longer recruiting|
|Oklahoma City, OK||University of Oklahoma Health Science Center||no longer recruiting|
|Fountain Hill, PA||Vita Hematology Oncology, P.C.||no longer recruiting|
|Collierville, TN||The Family Cancer Center||no longer recruiting|
|Germantown, TN||Mid-South Cancer Center||no longer recruiting|
|Austin, TX||Lone Star Oncology Consultants||no longer recruiting|
|Austin, TX||Southwest Regional Cancer Center||no longer recruiting|
|Dallas, TX||Mary Crowley Medical Research Center||no longer recruiting|
|Ogden, UT||Northern Utah Associates||no longer recruiting|
|Arlington, VA||Cancer Outreach Associates, LLC||no longer recruiting|
|Seattle, WA||Virginia Mason Medical Center||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: up to 3 years post treatment
progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety
time frame: up to 3 years post treatment
Female participants at least 18 years old.
- 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.
|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|
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