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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00576225
Other study ID # PGT307
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date September 2007
Est. completion date April 5, 2010

Study information

Verified date October 2020
Source CTI BioPharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 5, 2010
Est. primary completion date April 5, 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
United States Cancer Outreach Associates, LLC Arlington Virginia
United States Lone Star Oncology Consultants Austin Texas
United States Southwest Regional Cancer Center Austin Texas
United States St Alexius Medical Center Bismarck North Dakota
United States Providence St. Joseph Medical Center Burbank California
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 The Family Cancer Center Collierville Tennessee
United States Mary Crowley Medical Research Center Dallas Texas
United States Henry Ford Health System, Josephine Ford Cancer Center Detroit Michigan
United States Southwest Cancer Care Escondido California
United States Broward Oncology Associates Fort Lauderdale Florida
United States Hembree Regional Cancer Center Fort Smith Arkansas
United States Vita Hematology Oncology, P.C. Fountain Hill Pennsylvania
United States W. Michigan Regional Cancer & Blood Center Free Soil Michigan
United States Mid-South Cancer Center Germantown Tennessee
United States Hartford Hospital Hartford Connecticut
United States Hattiesburg Clinic Hattiesburg Mississippi
United States Las Vegas Cancer Center Henderson Nevada
United States Horizon Institute for Clinical Research Hollywood Florida
United States Memorial Cancer Institute Hollywood Florida
United States Columbia Comprehensive Cancer Care Clinics Jefferson City Missouri
United States Joliet Oncology Hematology Associates, Ltd Joliet Illinois
United States Loyola University Maywood Illinois
United States Clinical Trials & Research Institute Montebello California
United States Hematology Oncology Consultants Naperville Illinois
United States Cancer Care Center New Albany Indiana
United States Arena Oncology Associates New York New York
United States Lincoln Medical and Mental Health Center New York New York
United States Northern Utah Associates Ogden Utah
United States University of Oklahoma Health Science Center Oklahoma City Oklahoma
United States Kansas City Cancer Center Overland Park Kansas
United States VA Sierra Nevada Health Care System Reno Nevada
United States St. Louis University Saint Louis Missouri
United States Mayo Clinic Scottsdale Arizona
United States Scottsdale Medical Specialists Scottsdale Arizona
United States Virginia Mason Medical Center Seattle Washington
United States Stanford Cancer Center Stanford California
United States Richmond University Medical Center Staten Island New York
United States Pasco Pinellas Cancer Center Tarpon Springs Florida
United States Providence Medical Group Terre Haute Indiana
United States New York Medical College Valhalla New York
United States Family Medicine of Vincennes Clinical Trials Center Vincennes Indiana

Sponsors (1)

Lead Sponsor Collaborator
CTI BioPharma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival up to 3 years post treatment
Secondary progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety up to 3 years post treatment
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