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

NCT ID: NCT00592007

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2012-04-30

Brief 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.

Conditions

Non Small Cell Lung Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Single-arm study

Group Type: EXPERIMENTAL

Fulvestrant and Erlotinib

Intervention Type: DRUG

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.

Interventions

Fulvestrant and Erlotinib

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 Type: DRUG

Other Intervention Names

Faslodex and Erlotinib

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Lyudmila Bazhenova, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Lyudmila Bazhenova, M.D.

Assistant Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lyudmila Bazhenova, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Moores UCSD Cancer Center

La Jolla, California, United States

Countries

United States

Related Links

http://cancer.ucsd.edu/

Moores UCSD Cancer Center Homepage

Other Identifiers

HRPP# 060769

Identifier Type: -

Identifier Source: secondary_id

UCSD-060769

Identifier Type: -

Identifier Source: org_study_id