- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00592007
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
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La Jolla, California, United States, 92093-0698
- Moores UCSD Cancer Center
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Single-arm study
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free Survival
Time Frame: 14 weeks after start of fulvestrant
|
14 weeks after start of fulvestrant
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: Patients will be followed until death
|
Patients will be followed until death
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lyudmila Bazhenova, M.D., University of California, San Diego
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protein Kinase Inhibitors
- Hormone Antagonists
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Erlotinib Hydrochloride
- Fulvestrant
Other Study ID Numbers
- UCSD-060769
- HRPP# 060769
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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