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

NCT00592007 | Terminated Phase 2 Results DMC

• 2 other identifiers: UCSD-060769HRPP# 060769
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Carcinoma

Keywords

Non Small Cell Lung Cancer; Stage IIIB; Stage IV; Stable on Erlotinib; Exhibit Positivity for Estrogen or Progesterone Receptor

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  14 weeks after start of fulvestrant

Secondary Outcomes (1)

• Overall Survival

  Patients will be followed until death

Study Arms (1)

A

EXPERIMENTAL

Single-arm study

Drug: Fulvestrant and Erlotinib

Interventions

Fulvestrant and Erlotinib 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.

Also known as: Faslodex and Erlotinib

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lyudmila Bazhenova, M.D.: lead
• AstraZeneca: collaborator

Study Sites (1)

Moores UCSD Cancer Center

La Jolla, California, 92093-0698, United States

Location

Related Links

• Moores UCSD Cancer Center Homepage

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Fulvestrant; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Lyudmila Bazhenova, MD
• Organization: UC San Diego, Moores Cancer Center

lbazhenova@ucsd.edu

858 822 6189

Study Officials

• Lyudmila Bazhenova, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 11, 2008
• Study Start: September 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 6, 2017
• Results First Posted: June 6, 2017

Record last verified: 2017-05

Locations

US (1)