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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Non Small Cell Lung Carcinoma

Intervention / Treatment
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* Drug: Fulvestrant and Erlotinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Single-arm study | Drug: Fulvestrant and Erlotinib<br>* 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.<br>* Other names: Faslodex and Erlotinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival |  | 14 weeks after start of fulvestrant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Patients will be followed until death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Small Cell Lung Cancer, Stage IIIB, Stage IV, Stable on Erlotinib, Exhibit Positivity for Estrogen or Progesterone Receptor