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

Non Small Cell Lung Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00592007
• Other study ID #: UCSD-060769
• Secondary ID: HRPP# 060769
• Status: Terminated
• Phase: Phase 2
• First received: December 26, 2007
• Last updated: July 12, 2012
• Start date: September 2007
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Carcinoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Moores UCSD Cancer Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Lyudmila Bazhenova, M.D.	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		14 weeks after start of fulvestrant	No
Secondary	Overall survival		Patients will be followed until death	No
Secondary	Compare progression-free survival and time to progression with historical controls from similar patients at the Moores UCSD Cancer Center		14 weeks after start of fulvestrant	No
Secondary	Response rate		Response assessment every 2 months	No
Secondary	Compare the progression-free survival using fulvestrant in addition to erlotinib with comparable historical controls on monotherapy alone from the original phase III efficacy trial of erlotinib		14 weeks after start of fulvestrant	No
Secondary	Monitor the toxicities of the combination of fulvestrant and erlotinib		Day 14 and 28 of Cycle 1 and Day 1 of each subsequent cycles	Yes
Secondary	Study the association between tumor response ER or PR positivity by IHC		one-time measurement	No
Secondary	Study the association between tumor response and ER alpha and beta expression by PCR		one-time measurement	No
Secondary	Study the association between gender and ER alpha and beta expression as determined by IHC or PCR		one-time measurement	No

External Links

•   Moores UCSD Cancer Center Homepage