CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL
NCT ID: NCT00576225
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2007-09-30
2010-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental
CT-2103/carboplatin
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.
Control
paclitaxel/carboplatin
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.
Interventions
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CT-2103/carboplatin
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.
paclitaxel/carboplatin
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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CTI BioPharma
INDUSTRY
Responsible Party
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Principal Investigators
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Jack W. Singer, M.D.
Role: STUDY_DIRECTOR
CTI BioPharma
Locations
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Scottsdale Medical Specialists
Scottsdale, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Hembree Regional Cancer Center
Fort Smith, Arkansas, United States
Providence St. Joseph Medical Center
Burbank, California, United States
Southwest Cancer Care
Escondido, California, United States
Clinical Trials & Research Institute
Montebello, California, United States
Stanford Cancer Center
Stanford, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Broward Oncology Associates
Fort Lauderdale, Florida, United States
Horizon Institute for Clinical Research
Hollywood, Florida, United States
Memorial Cancer Institute
Hollywood, Florida, United States
Pasco Pinellas Cancer Center
Tarpon Springs, Florida, United States
Joliet Oncology Hematology Associates, Ltd
Joliet, Illinois, United States
Loyola University
Maywood, Illinois, United States
Hematology Oncology Consultants
Naperville, Illinois, United States
Cancer Care Center
New Albany, Indiana, United States
Providence Medical Group
Terre Haute, Indiana, United States
Family Medicine of Vincennes Clinical Trials Center
Vincennes, Indiana, United States
Kansas City Cancer Center
Overland Park, Kansas, United States
Henry Ford Health System, Josephine Ford Cancer Center
Detroit, Michigan, United States
W. Michigan Regional Cancer & Blood Center
Free Soil, Michigan, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Columbia Comprehensive Cancer Care Clinics
Jefferson City, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Las Vegas Cancer Center
Henderson, Nevada, United States
VA Sierra Nevada Health Care System
Reno, Nevada, United States
Lincoln Medical and Mental Health Center
New York, New York, United States
Arena Oncology Associates
New York, New York, United States
Richmond University Medical Center
Staten Island, New York, United States
New York Medical College
Valhalla, New York, United States
St Alexius Medical Center
Bismarck, North Dakota, United States
Blood and Cancer Center
Canfield, Ohio, United States
Aultman Hospital Clinical Trials
Canton, Ohio, 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
Vita Hematology Oncology, P.C.
Fountain Hill, Pennsylvania, United States
The Family Cancer Center
Collierville, Tennessee, United States
Mid-South Cancer Center
Germantown, Tennessee, United States
Southwest Regional Cancer Center
Austin, Texas, United States
Lone Star Oncology Consultants
Austin, Texas, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Northern Utah Associates
Ogden, Utah, United States
Cancer Outreach Associates, LLC
Arlington, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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PGT307
Identifier Type: -
Identifier Source: org_study_id
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