Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer
Condition: Non Small Cell Lung Carcinoma
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Fulvestrant and Erlotinib
Intervention description: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress.
Intervention MeSH terms: Erlotinib Hydrochloride; Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non Small Cell Lung Cancer; Stage IIIB; Stage IV; Stable on Erlotinib; Exhibit Positivity for Estrogen or Progesterone Receptor

Summary:

      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.
    

Eligibility criteria:

        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.