NCT00932152

Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-small Cell Lung Cancer

A Phase II Randomized Trial of Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-small Cell Lung Cancer Who Have Received First-line Platinum-based Chemotherapy With or Without Bevacizumab

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer
• Postmenopausal Women

Interventions

Type	Name	Description
DRUG	fulvestrant (Faslodex)	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.
DRUG	anastrozole (Arimidex)	Anastrozole (Arimidex) 1 mg orally QD
DRUG	Bevacizumab (Avastin)	Bevacizumab (Avastin) 15 mg/kg IV, every 21 days
DRUG	Best supportive care	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

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2009-07-03
• Last updated: 2017-10-19
• Results posted: 2016-08-31

Locations

1 site across 1 country: United States