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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Carcinoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

14 weeks after start of fulvestrant

Safety Issue:

No

Principal Investigator

Lyudmila Bazhenova, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Diego

Authority:

United States: Institutional Review Board

Study ID:

UCSD-060769

NCT ID:

NCT00592007

Start Date:

September 2007

Completion Date:

July 2012

Related Keywords:

  • Non Small Cell Lung Carcinoma
  • Non Small Cell Lung Cancer
  • Stage IIIB
  • Stage IV
  • Stable on Erlotinib
  • Exhibit Positivity for Estrogen or Progesterone Receptor
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Moores UCSD Cancer CenterLa Jolla, California  92093-0658