CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL

Withdrawn before enrolling · Phase 3

Conditions studied: NSCLC

In brief

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.

Key facts

Study ID

NCT00576225

Run by

CTI BioPharma

People needed

0

Starts

2007-09-01

Expected to finish

2010-04-05

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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