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

Lyudmila Bazhenova, M.D.

Status and phase

Terminated

Phase 2

Conditions

Non Small Cell Lung Carcinoma

Treatments

Drug: Fulvestrant and Erlotinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00592007

UCSD-060769

HRPP# 060769

Details and patient eligibility

About

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.

Full description

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.