Non Small Cell Lung CarcinomaPhase 2NCT00592007
Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer
A Phase 2 study testing Fulvestrant and Erlotinib in people with Non Small Cell Lung Carcinoma, run by Lyudmila Bazhenova, M.D. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Carcinoma
- What is being tested?
- Fulvestrant and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Apr 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Moores UCSD Cancer Center
La Jolla, California, 92093-0698
About this study
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
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.
Read the 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
- Being tested
- Fulvestrant and Erlotinib
- Keywords
- Non Small Cell Lung Cancer, Stage IIIB, Stage IV, Stable on Erlotinib, Exhibit Positivity for Estrogen or Progesterone Receptor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fulvestrant and ErlotinibDrug
Also called Faslodex 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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Single-arm study Receives: Drug: Fulvestrant and Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Measured: 14 weeks after start of fulvestrant
Secondary outcomes (1)
Overall Survival
Measured: Patients will be followed until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionJan 2012
- Study completionApr 2012
Why it stopped: Study was terminated due to slow subject accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyudmila Bazhenova, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Lyudmila Bazhenova, M.D., University of California, San Diego
- Investigators
- Lyudmila Bazhenova, M.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592007
- Sponsor's protocol ID
- UCSD-060769
- Other IDs
- HRPP# 060769
- Status last verified
- May 2017
- First submitted
- 26 Dec 2007
- Last updated
- 6 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00592007
- Acronym / sponsor ID
- UCSD-060769
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to slow subject accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Lyudmila Bazhenova, M.D.University, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Sep 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 6 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Fulvestrant and ErlotinibSingle-arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fulvestrant and ErlotinibAlso: Faslodex and ErlotinibUpon 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. | Drug | A |
Primary outcome
Progression-free Survival
Time frame: 14 weeks after start of fulvestrant
1 secondary outcome
Overall Survival
Time frame: Patients will be followed until death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Moores UCSD Cancer Center HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyudmila Bazhenova, M.D. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fulvestrant and Erlotinib in people with Non Small Cell Lung Carcinoma, run by Lyudmila Bazhenova, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: 14 weeks after start of fulvestrant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.