Trial of ZD6474 and Faslodex in Non-Small Cell Lung Cancer
The purpose of this study is to evaluate the safety and tolerability of vandetanib and fulvestrant; to find the maximum tolerated dose of these two drugs; and to evaluate response rate and assess toxicity of this combination.
Carcinoma, Non Small Cell Lung
Drug: ZD6474 (vandetanib)
Drug: Faslodex (Fulvestrant)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Vandetanib (ZD6474, Zactima) and Fulvestrant (Faslodex) as Third-Line Treatment of Advanced Non-Small Cell Lung Cancer|
- Toleration of combination of fulvestrant/vandetanib [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
- Response rate to combination of fulvestrant/vandetanib [ Time Frame: End of trial ] [ Designated as safety issue: No ]
- Safety of combination of fulvestrant/vandetanib [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||May 2011|
|Estimated Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: Vandetanib plus fulvestrant
vandetanib by mouth once daily for 28 days plus fulvestrant intra-muscular injection each cycle
Drug: ZD6474 (vandetanib)
vandetanib (100 mg or 200 mg or 300 mg) by mouth once daily for 28 days
Other Name: ZD6474, ZactimaDrug: Faslodex (Fulvestrant)
Fulvestrant 500 mg intra-muscular injection on Day 1 and 250 mg Day 15 of cycle 1 Cycles 2 and beyond: Fulvestrant 500 mg intra-muscular injection on Day 1, every 28 days.
Other Name: Faslodex
Current treatment for metastatic non-small cell lung cancer (NSCLC) is inadequate, with a median survival of 8-12 months. Second-line therapy options include cytotoxic agents or molecularly-targeted agents such as erlotinib. Nevertheless, only 7-9% of patients will respond to standard second-line treatment. Treatment-related side effects from cytotoxic drugs and declining performance status in patients with progressing disease are significant issues in this patient population. Novel approaches with molecularly-targeted agents are clearly needed.
The combination of vandetanib and fulvestrant addresses the potential to interfere with multiple interdependent growth-stimulatory pathways simultaneously. Recent work has revealed cross-talk between epidermal growth factor receptor (EGFR) and estrogen receptor (ER) pathways. This clinical trial will evaluate the clinical interaction of the EGFR inhibitor, vandetanib, in combination with the ER down-regulator, fulvestrant.
|United States, Wisconsin|
|University of Wisconsin - Madison|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Tien Hoang, M.D.||University of Wisconsin, Madison|