Non-small Cell Lung CancerPhase 2NCT00932152
Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-small Cell Lung Cancer
A Phase 2 study testing fulvestrant (Faslodex), anastrozole (Arimidex) and Bevacizumab (Avastin) in people with Non-small Cell Lung Cancer and Postmenopausal Women, run by University of Pittsburgh at 1 site in United States.
Trial summary
This research study will test whether dual anti-estrogen therapy (anastrozole and fulvestrant) slows the time to when the cancer progresses. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Non-small Cell Lung Cancer, Postmenopausal Women
- What is being tested?
- fulvestrant (Faslodex), anastrozole (Arimidex) and Bevacizumab (Avastin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jan 2013
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC) (no component of small cell).
- Patients must have stage IIIB (with malignant pleural effusion), stage IV NSCLC (as staged by the AJCC Cancer Staging Manual. 6th ed, appendix 1) or stage IV NSCLC as staged by the new AJCC staging system
- Patients with recurrent NSCLC should have recurred 12 months or more after completion of prior chemotherapy given in the context of curative therapy (chemoradiotherapy or adjuvant therapy) are eligible
- Patients should have been treated with 4 cycles of induction chemotherapy utilizing the following regimens: carboplatin/paclitaxel, carboplatin/gemcitabine, carboplatin/paclitaxel + bevacizumab, carboplatin/gemcitabine + bevacizumab, or carboplatin/pemetrexed +/- bevacizumab, (see Section 3.2 for acceptable doses and schedules) and should have CR, PR, or SD as best response.
- Patients should not have progressed on prior chemotherapy for metastatic or recurrent NSCLC.
- Must be postmenopausal female, as defined by the following criteria:
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- Prior bilateral oophorectomy or
- Age greater than 60 years old
- Age less than 60 years old and amenorrheic for 12 or more months in the absence of chemotherapy or ovarian suppression with FSH and estradiol in the postmenopausal range.
- Registration/randomization should be within 6 weeks of beginning of last cycle of chemotherapy
- Documented evidence of a tumor response of CR, PR, or SD. Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. Tumor assessment will be per RECIST (Appendix 3) by the treating physician. This response does not have to be confirmed in order for the patient to be randomized; however, unconfirmed responses will be stratified in the stable disease strata. Positron emission tomography (PET) scans and ultrasound may not be used for lesion measurements for response determination
- ECOG performance status 0, 1 or 2.
- At least 18 years of age.
- Adequate organ function, including the following:
- Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) greater than or equal to 1.0 x10^9/L, platelets greater than or equal to 75 x10^9/L, and hemoglobin greater than or equal to 9 g/dL.
- Hepatic: bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) less than or equal to 2.0 Renal: calculated creatinine clearance (CrCl) ≥45 mL/min based on the standard Cockcroft and Gault formula (Cockcroft and Gault 1976).
- Prior radiotherapy must be completed at least 3 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
- Signed informed consent document on file.
- Patient compliance and geographic proximity that allow adequate follow up.
- Patient must receive on-study therapy no earlier than 21 days and no later than 42 days from their last cycle (Day 1) of induction therapy.
- Patients must have archival tissue samples. Tumor tissue will be submitted for assessment of ERa, ERb, PR, VEGF and aromatase expression. The patient must also agree to mandatory correlative blood samples at baseline, 5 weeks, 9 weeks, 13 weeks and at the time of progression.
- Cisplatin may be used instead of carboplatin as part of the initial induction chemotherapy regimen, at the discretion of the treating physician investigator. The dose and schedule of cisplatin will be according to the standard of care for patients with stage IIIB with malignant pleural effusion or stage IV NSCLC as staged by the AJCC Cancer Staging Manual, 6th ed, appendix 1, that is equivalent to stage IV NSCLC as staged by the new 7th ed AJCC staging system.
Who cannot join
- Male gender
- With the exception of those chemotherapies listed as Inclusion criterion (4) No other concomitant biological therapy (e.g. cetuximab) is allowed.
- Have received experimental treatment within the last 30 days at the time of study entry.
- Inability to comply with protocol or study procedures.
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- Concurrent administration of any other antitumor therapy (except arm B, who are allowed to continue with bevacizumab).
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- Pregnant or breast feeding.
- Have a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
- Patients with two or more deep vein thromboses, or an active deep vein thrombosis.
- Patients taking hormone replacement therapy or other hormonal therapies
- The International Normalized Ratio (INR) must be < 1.6 within 28 days prior to registration.
- Patients with bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting factor deficiency) or a history of recent history of hemoptysis (1/2 tsp of red blood). Patients on stable long term anticoagulation prior to starting this trial are allowed.
- History of hypersensitivity to active or inactive excipients of fulvestrant (ie castor oil or Mannitol).
- Treatment of NSCLC with squamous cell histology with bevacizumab.
- No progressive Brain or CNS metastases
- No other concurrent anticancer therapy is allowed other than Bevacizumab
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase II Randomized Trial of Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-small Cell Lung Cancer Who Have Received First-line Platinum-based Chemotherapy With or Without Bevacizumab
This research study will test whether dual anti-estrogen therapy (anastrozole and fulvestrant) slows the time to when the cancer progresses.
Read the detailed description
Women invited to participate in this study must be post-menopausal and be 18 years of age or older. The study is being performed on a total of 100 individuals. Of this group, 75 will be in the Treatment Groups using Fulvestrant/Anastrozole with our without bevacizumab and 25 will be in the "Best Supportive Care" groups receiving no treatment or just bevacizumab at the University of Pittsburgh Medical Center.
- Conditions
- Non-small Cell Lung Cancer, Postmenopausal Women
- Being tested
- fulvestrant (Faslodex), anastrozole (Arimidex), Bevacizumab (Avastin), Best supportive care
- Keywords
- advanced non-small cell lung cancer, postmenopausal, bevacizumab, fulvestrant, anastrozole
- 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 (Faslodex)Drug
Fulvestrant (Faslodex) IM 250 mg monthly after a loading dose of 500 mg on day 1 and 250 mg on day 15 of cycle 1.
anastrozole (Arimidex)Drug
Anastrozole (Arimidex) 1 mg orally QD
Bevacizumab (Avastin)Drug
Bevacizumab (Avastin) 15 mg/kg IV, every 21 days
Best supportive careDrug
Also called Antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support
Subjects will not receive any chemotherapy for NSCLC nor will they received anti-cancer surgery, immunotherapy, radiotherapy or hormonal therapy. Among the therapies they may take are therapies considered acceptable include, but are not limited to, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral
| Study group | Role | What they receive |
|---|---|---|
| Arm B, Group 1 | Active comparator | Best supportive care only: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support PRN Receives: Drug: Best supportive care |
| Arm B, Group 2 | Active comparator | Best supportive care and Bevacizumab 15mg/kg every 21 days Receives: Drug: Bevacizumab (Avastin); Drug: Best supportive care |
| Arm A, Group 1 | Experimental | Fulvestrant and anastrozole only Receives: Drug: fulvestrant (Faslodex); Drug: anastrozole (Arimidex) |
| Arm A, Group 2 | Experimental | Fulvestrant, anastrozole and Bevacizumab Receives: Drug: fulvestrant (Faslodex); Drug: anastrozole (Arimidex); Drug: Bevacizumab (Avastin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Progression-free Survival.
Measured: 1.5 years
Secondary outcomes (3)
To Evaluate the Time to Overall Survival, Time to Progression, and Toxicities
Measured: 1.5 years
To Evaluate the Levels of 17b-estradiol, VEGF, E-selectin, Thrombospondin-1 and IGF-1, and Other Biomarkers in the Plasma.
Measured: 1.5 years
To Evaluate Biomarkers (ERa, ERb, PR, VEGF and Aromatase Expression) in Baseline, Archival Tumor Tissue and Correlate Their Expression With Progression-free Survival, Time to Progression, and Overall Survival.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startSep 2010
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Poor enrollment/suspended to accrual; will close per AstraZeneca request
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 CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Tarhini, University of Pittsburgh
- Investigators
- Ahmad Tarhini, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932152
- Sponsor's protocol ID
- UPCI 08-131
- Status last verified
- Sep 2017
- First submitted
- 1 Jul 2009
- Last updated
- 19 Oct 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 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial of Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-small Cell Lung Cancer Who Have Received First-line Platinum-based Chemotherapy With or Without Bevacizumab
- ClinicalTrials.gov ID
- NCT00932152
- Acronym / sponsor ID
- UPCI 08-131
- Conditions
- Non-small Cell Lung Cancer, Postmenopausal Women
- Keywords
- advanced non-small cell lung cancer, postmenopausal, bevacizumab, fulvestrant, anastrozole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment/suspended to accrual; will close per AstraZeneca request
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 Jul 2009 (estimated)
- Results
- Posted 31 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study will test whether dual anti-estrogen therapy (anastrozole and fulvestrant) slows the time to when the cancer progresses.
Detailed description
Women invited to participate in this study must be post-menopausal and be 18 years of age or older. The study is being performed on a total of 100 individuals. Of this group, 75 will be in the Treatment Groups using Fulvestrant/Anastrozole with our without bevacizumab and 25 will be in the "Best Supportive Care" groups receiving no treatment or just bevacizumab at the University of Pittsburgh Medical Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm B, Group 1 | Active comparator | Drug: Best supportive careBest supportive care only: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support PRN |
| Arm B, Group 2 | Active comparator | Drug: Bevacizumab (Avastin), Drug: Best supportive careBest supportive care and Bevacizumab 15mg/kg every 21 days |
| Arm A, Group 1 | Experimental | Drug: fulvestrant (Faslodex), Drug: anastrozole (Arimidex)Fulvestrant and anastrozole only |
| Arm A, Group 2 | Experimental | Drug: fulvestrant (Faslodex), Drug: anastrozole (Arimidex), Drug: Bevacizumab (Avastin)Fulvestrant, anastrozole and Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC) (no component of small cell).
- Patients must have stage IIIB (with malignant pleural effusion), stage IV NSCLC (as staged by the AJCC Cancer Staging Manual. 6th ed, appendix 1) or stage IV NSCLC as staged by the new AJCC staging system
- Patients with recurrent NSCLC should have recurred 12 months or more after completion of prior chemotherapy given in the context of curative therapy (chemoradiotherapy or adjuvant therapy) are eligible
- Patients should have been treated with 4 cycles of induction chemotherapy utilizing the following regimens: carboplatin/paclitaxel, carboplatin/gemcitabine, carboplatin/paclitaxel + bevacizumab, carboplatin/gemcitabine + bevacizumab, or carboplatin/pemetrexed +/- bevacizumab, (see Section 3.2 for acceptable doses and schedules) and should have CR, PR, or SD as best response.
- Patients should not have progressed on prior chemotherapy for metastatic or recurrent NSCLC.
Key exclusion criteria (16 listed)
- Male gender
- With the exception of those chemotherapies listed as Inclusion criterion (4) No other concomitant biological therapy (e.g. cetuximab) is allowed.
- Have received experimental treatment within the last 30 days at the time of study entry.
- Inability to comply with protocol or study procedures.
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
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 (Faslodex)Fulvestrant (Faslodex) IM 250 mg monthly after a loading dose of 500 mg on day 1 and 250 mg on day 15 of cycle 1. | Drug | Arm A, Group 1, Arm A, Group 2 |
| anastrozole (Arimidex)Anastrozole (Arimidex) 1 mg orally QD | Drug | Arm A, Group 1, Arm A, Group 2 |
| Bevacizumab (Avastin)Bevacizumab (Avastin) 15 mg/kg IV, every 21 days | Drug | Arm A, Group 2, Arm B, Group 2 |
| Best supportive careAlso: Antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional supportSubjects will not receive any chemotherapy for NSCLC nor will they received anti-cancer surgery, immunotherapy, radiotherapy or hormonal therapy. Among the therapies they may take are therapies considered acceptable include, but are not limited to, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral | Drug | Arm B, Group 1, Arm B, Group 2 |
Primary outcome
To Evaluate the Progression-free Survival.
Time frame: 1.5 years
3 secondary outcomes
To Evaluate the Time to Overall Survival, Time to Progression, and Toxicities
Time frame: 1.5 years
To Evaluate the Levels of 17b-estradiol, VEGF, E-selectin, Thrombospondin-1 and IGF-1, and Other Biomarkers in the Plasma.
Time frame: 1.5 years
To Evaluate Biomarkers (ERa, ERb, PR, VEGF and Aromatase Expression) in Baseline, Archival Tumor Tissue and Correlate Their Expression With Progression-free Survival, Time to Progression, and Overall Survival.
Time frame: 1.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ahmad Tarhini, MD principal investigator
University of Pittsburgh Medical Center
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 (Faslodex), anastrozole (Arimidex) and Bevacizumab (Avastin) in people with Non-small Cell Lung Cancer and Postmenopausal Women, run by University of Pittsburgh 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 22 inclusion and 16 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 19 Oct 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 31 Aug 2016). 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?
To Evaluate the Progression-free Survival. (time frame: 1.5 years). 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 19 Oct 2017.