Trial of ZD6474 and Faslodex in Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01004419|
Recruitment Status : Withdrawn (Support for investigational products has been withdrawn.)
First Posted : October 30, 2009
Last Update Posted : October 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non Small Cell Lung||Drug: ZD6474 (vandetanib) Drug: Faslodex (Fulvestrant)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Vandetanib (ZD6474, Zactima) and Fulvestrant (Faslodex) as Third-Line Treatment of Advanced Non-Small Cell Lung Cancer|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||May 2011|
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, Zactima
Drug: 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
- Toleration of combination of fulvestrant/vandetanib [ Time Frame: Monthly ]
- Response rate to combination of fulvestrant/vandetanib [ Time Frame: End of trial ]
- Safety of combination of fulvestrant/vandetanib [ Time Frame: Monthly ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004419
|Principal Investigator:||Tien Hoang, M.D.||University of Wisconsin, Madison|