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Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT00592007•Lyudmila Bazhenova, M.D.

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (1)

Moores UCSD Cancer Center

La Jolla, California, United States

Key Dates

Start Date

September 1, 2007

Primary Completion Date

January 1, 2012

Completion Date

April 1, 2012

Last Updated

June 6, 2017

Enrollment

ACTUAL participants

Conditions

Non Small Cell Lung Carcinoma

Interventions

Fulvestrant and Erlotinib

DRUG

Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.

NCT00759382

Non Small Cell Lung Carcinoma

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COMPLETEDPHASE1

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NCT00635791

Malignant Solid TumourRenal Cell Carcinoma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.

Phase I Study of Vorinostat and Sorafenib in Advanced Cancer

Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC