Conditions: Non-small Cell Lung Cancer Postmenopausal Women
Keywords: advanced non-small cell lung cancer postmenopausal bevacizumab fulvestrant anastrozole
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3
Healthy volunteers: no

Brief summary:
This research study will test whether dual anti-estrogen therapy (anastrozole and fulvestrant) slows the time to when the cancer progresses.

Detailed description:
Women invited to participate in this study must be post-menopausal and be 18 years of age or older. The study is being performed on a total of 100 individuals. Of this group, 75 will be in the Treatment Groups using Fulvestrant/Anastrozole with our without bevacizumab and 25 will be in the "Best Supportive Care" groups receiving no treatment or just bevacizumab at the University of Pittsburgh Medical Center.

Arms:
arm 1: Best supportive care only: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support PRN arm 2: Best supportive care and Bevacizumab 15mg/kg every 21 days arm 3: Fulvestrant and anastrozole only arm 4: Fulvestrant, anastrozole and Bevacizumab

Interventions: intervention 1: fulvestrant (Faslodex) intervention 2: anastrozole (Arimidex) intervention 3: Bevacizumab (Avastin) intervention 4: Best supportive care
Intervention descriptions: intervention 1: Fulvestrant (Faslodex) IM 250 mg monthly after a loading dose of 500 mg on day 1 and 250 mg on day 15 of cycle 1. intervention 2: Anastrozole (Arimidex) 1 mg orally QD intervention 3: Bevacizumab (Avastin) 15 mg/kg IV, every 21 days intervention 4: Subjects will not receive any chemotherapy for NSCLC nor will they received anti-cancer surgery, immunotherapy, radiotherapy or hormonal therapy. Among the therapies they may take are therapies considered acceptable include, but are not limited to, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral

Protocol document: