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

• Overall survival [ Time Frame: Patients will be followed until death ] [ Designated as safety issue: No ]
• Compare progression-free survival and time to progression with historical controls from similar patients at the Moores UCSD Cancer Center [ Time Frame: 14 weeks after start of fulvestrant ] [ Designated as safety issue: No ]
• Response rate [ Time Frame: Response assessment every 2 months ] [ Designated as safety issue: No ]
• Compare the progression-free survival using fulvestrant in addition to erlotinib with comparable historical controls on monotherapy alone from the original phase III efficacy trial of erlotinib [ Time Frame: 14 weeks after start of fulvestrant ] [ Designated as safety issue: No ]
• Monitor the toxicities of the combination of fulvestrant and erlotinib [ Time Frame: Day 14 and 28 of Cycle 1 and Day 1 of each subsequent cycles ] [ Designated as safety issue: Yes ]
• Study the association between tumor response ER or PR positivity by IHC [ Time Frame: one-time measurement ] [ Designated as safety issue: No ]
• Study the association between tumor response and ER alpha and beta expression by PCR [ Time Frame: one-time measurement ] [ Designated as safety issue: No ]
• Study the association between gender and ER alpha and beta expression as determined by IHC or PCR [ Time Frame: one-time measurement ] [ Designated as safety issue: No ]

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.