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

Phase II Trial Evaluating Addition of Fulvestrant to Erlotinib in Patients With Stage IIIB/IV NSCLC Who Are Stable on Erlotinib and Exhibit Positivity for Estrogen or Progesterone Receptor

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.

Erlotinib is an oral drug which is able to block endothelial growth factor receptor (EGFR). EGFR stimulates cancer cell growth. Fulvestrant (faslodex) block estrogen hormone from gaining access to tumor and stimulating the tumor cells to grow. Both of these drugs are already approved by FDA but have not been studied in this combination.

We will study if the combination of these drugs will delay treatment failure. Lung cancer tumors in both males and females can be sensitive to estrogen. Only patients whose tumor expresses the estrogen will be eligible for the trial. Estrogen sensitivity will be tested on previously removed tumor specimens.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.