Clinical trial NCT00576225: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: NSCLC
Keywords: NSCLC
women
CT-2103
paclitaxel
carboplatin
Lead sponsor: CTI BioPharma
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Survival
timeFrame: up to 3 years post treatment
Secondary outcomes:
measure: progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety
timeFrame: up to 3 years post treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Medical Specialists
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Fort Smith
country: United States
facility: Hembree Regional Cancer Center
state: Arkansas
city: Burbank
country: United States
facility: Providence St. Joseph Medical Center
state: California
city: Escondido
country: United States
facility: Southwest Cancer Care
state: California
city: Montebello
country: United States
facility: Clinical Trials & Research Institute
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Broward Oncology Associates
state: Florida
city: Hollywood
country: United States
facility: Horizon Institute for Clinical Research
state: Florida
city: Hollywood
country: United States
facility: Memorial Cancer Institute
state: Florida
city: Tarpon Springs
country: United States
facility: Pasco Pinellas Cancer Center
state: Florida
city: Joliet
country: United States
facility: Joliet Oncology Hematology Associates, Ltd
state: Illinois
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Naperville
country: United States
facility: Hematology Oncology Consultants
state: Illinois
city: New Albany
country: United States
facility: Cancer Care Center
state: Indiana
city: Terre Haute
country: United States
facility: Providence Medical Group
state: Indiana
city: Vincennes
country: United States
facility: Family Medicine of Vincennes Clinical Trials Center
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Cancer Center
state: Kansas
city: Detroit
country: United States
facility: Henry Ford Health System, Josephine Ford Cancer Center
state: Michigan
city: Free Soil
country: United States
facility: W. Michigan Regional Cancer & Blood Center
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Jefferson City
country: United States
facility: Columbia Comprehensive Cancer Care Clinics
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Henderson
country: United States
facility: Las Vegas Cancer Center
state: Nevada
city: Reno
country: United States
facility: VA Sierra Nevada Health Care System
state: Nevada
city: New York
country: United States
facility: Lincoln Medical and Mental Health Center
state: New York
city: New York
country: United States
facility: Arena Oncology Associates
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Bismarck
country: United States
facility: St Alexius Medical Center
state: North Dakota
city: Canfield
country: United States
facility: Blood and Cancer Center
state: Ohio
city: Canton
country: United States
facility: Aultman Hospital Clinical Trials
state: Ohio
city: Cincinnati
country: United States
facility: UIMA, Inc / University of Cincinnati-Barrett Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Fountain Hill
country: United States
facility: Vita Hematology Oncology, P.C.
state: Pennsylvania
city: Collierville
country: United States
facility: The Family Cancer Center
state: Tennessee
city: Germantown
country: United States
facility: Mid-South Cancer Center
state: Tennessee
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Austin
country: United States
facility: Lone Star Oncology Consultants
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Arlington
country: United States
facility: Cancer Outreach Associates, LLC
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: CTI BioPharma
name: Jack W. Singer, M.D.
role: STUDY_DIRECTOR
References: