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

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lyudmila Bazhenova, M.D.
• Collaborator: AstraZeneca
• Treatments: Erlotinib Hydrochloride; Estradiol; Estrogens; Fulvestrant; Progesterone

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.