Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer

Stopped early · Phase 2

Conditions studied: Non Small Cell Lung Carcinoma

In brief

The main purpose of this research study is to see if adding fulvestrant (Faslodex) to erlotinib (Tarceva) is effective in patients with stage IIIb/IV Non-Small Cell Lung Cancer.

Key facts

Study ID

NCT00592007

Run by

Lyudmila Bazhenova, M.D.

People needed

7

Starts

2007-09-01

Expected to finish

2012-04-01

Last updated by the study team

2017-06-06

Who can join

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

You may qualify if…

• Estrogen or progesterone receptor positive stage IIIb/IV non-small cell lung cancer
• Eligible patients will have stable disease on erlotinib monotherapy at FDA- approved doses after a minimum duration of erlotinib therapy of 2 months
• 18 years or older
• ECOG Performance Status ≤2
• Adequate Organ Function Requirements
• Adequate coagulation function
• Postmenopausal status in female patients is required and is defined as no menstrual periods for 12 month or surgical menopause
• All patients must sign a written informed consent.

You may not qualify if…

• Pregnant or breast-feeding women will not be entered on this study
• Patients who are currently receiving another investigational drugs
• Patients who are currently receiving other anti-cancer agents.
• Hormone replacement therapy will not be allowed and have to be stopped 1 month prior to entry into the study
• Patients who have an uncontrolled infection.
• Patients receiving less than 100mg/day of erlotinib
• Patients with evidence of progression after 2 months of erlotinib monotherapy.
• Patients with a history of bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy).
• Patients with a history of hypersensitivity to active or inactive excipients of fulvestrant (i.e. castor oil or Mannitol).
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

Where it is running

• Moores UCSD Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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