Lung CancerPhase 2NCT00100854
Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing erlotinib hydrochloride and fulvestrant in people with Lung Cancer, run by Translational Oncology Research International at 1 site in United States.
Trial summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of non-small cell lung cancer cells. Hormone therapy using fulvestrant may fight non-small cell lung cancer by lowering the amount of estrogen the body makes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- erlotinib hydrochloride and fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2004to 5 Sep 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- adults over the age of 18 capable of giving informed consent.
- Histologically confirmed non-small cell lung cancer
- Stage IIIB or IV NSCLC
- Tumor tissue block available.
- ECOG performance status of 0, 1 or 2.
- Measurable disease by RECIST criteria defined as ≥ 1 target lesion that has not been irradiated. New lesions that have developed in a previously irradiated field may be used as sites of measurable disease provided all other criteria are met.
Show all 11Show fewer
- Meets 1 of the following criteria:
- Progressive disease after ≥ 1 prior standard chemotherapy regimen
- Refused chemotherapy
- Unable to receive standard chemotherapy
- women of childbearing age must have negative pregnancy test by urine or serum prior to initiation of treatment. men and women of childbearing potential must consent to using adequate contraception throughout treatment and for 3 months following surgery.
Who cannot join
- Renal insufficiency (serum creatinine >2mg/dl)
- Liver insufficiency (serum total bilirubin >1.5X ULN, or serum transaminases > 2.5X the ULN or %X ULN if hepatic metastases).
- hematologic abnormality platelets< 100,000 ANC <1,500/mm3
- THerapeutic anticoagulation will be allowed, but patients receiving fulvestrant while on therapeutic anticoagulation will have the fulvestrant dose divided into twice as many syringes to minimize the volume of intramuscular injection in these patients. In patients receiving low molecular weight heparin or fondaparinux, these medications should be held for 12 hours before and after fulvestrant injection if possible.
- Active CNS metastases.
- New York Heart Association class III or IV cardiac disease
Show all 26Show fewer
- myocardial infarction within the past 12 months
- symptomatic ventricular arrhythmia
- symptomatic conduction abnormality
- evidence of clinically active interstitial lung disease
- Patients with asymptomatic chronic stable radiographic changes are eligible
- pregnant or nursing or inadequate contraception
- hypersensitivity to erlotinib hydrochloride or fulvestrant or to any of their excipients
- comorbid disease or medical condition that would preclude study treatment or compliance
- malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- chemotherapy or non-cytotoxic investigational agents within 4 weeks of initiating treatment.
- major surgery within 4 weeks of initiating therapy. Minor surgery within 7 days of initiating therapy.
- anticancer antiestrogen therapy. Concurrent stable-dose steroids allowed
- concomitant radiation therapy to the lungs. Radiation therapy to non-target lesions will be allowed as long as it is completed 1 week prior to initiation of treatment.
- prior anticancer epidermal growth factor receptor inhibitors
- concurrent CYP3A4 inducers, including any of the following:
- Phenytoin
- Carbamazepine
- Rifampin
- Barbiturates
- Hypericum perforatum (St. John's wort)
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
About this study
Official title: A Randomized, Open-Label Phase II Clinical Trial of Combination Erlotinib (Tarceva®) and Fulvestrant (Faslodex®) Versus Erlotinib (Tarceva®) Alone in Advanced Non-Small Cell Lung Cancer Patients
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of non-small cell lung cancer cells. Hormone therapy using fulvestrant may fight non-small cell lung cancer by lowering the amount of estrogen the body makes. Giving erlotinib together with fulvestrant may kill more tumor cells. It is not yet known whether giving erlotinib together with fulvestrant is more effective than erlotinib alone in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying giving erlotinib together with fulvestrant to see how well it works compared to erlotinib alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare objective tumor response in patients stage IIIB or IV non-small cell lung cancer treated with erlotinib hydrochloride with vs without fulvestrant.
Secondary
- Correlate response rate with ER and EGF receptor expression in patients treated with these regimens.
- Correlate measurement of ER-α, ER-β, EGF/HER-1 receptor and HER-2/neu receptor with clinical response in patients treated with these regimens.
- Correlate erlotinib hydrochloride resistance with ER and HER receptor expression in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status, gender, and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days.
- Arm II: Patients receive erlotinib hydrochloride as in arm I and fulvestrant intramuscularly on days 1, 15, and 29, and then every 28 days thereafter.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 30 days and then every 2 months until disease progression.
PROJECTED ACCRUAL: A total of 102 patients (34 in arm I and 68 in arm II) will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- erlotinib hydrochloride, fulvestrant
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinib hydrochlorideDrug
Given orally
fulvestrantDrug
Given intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days. Receives: Drug: erlotinib hydrochloride |
| Arm II | Experimental | Patients receive erlotinib hydrochloride as in arm I and fulvestrant intramuscularly on days 1, 15, and 29, and then every 28 days thereafter. Receives: Drug: erlotinib hydrochloride; Drug: fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor response
Measured: 30 days
Secondary outcomes (1)
Correlation of response rate with receptor expression
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2005 (estimated)
- Study start28 Oct 2004
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Oncology Research International
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Edward Garon, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100854
- Sponsor's protocol ID
- CDR0000407580
- Other IDs
- P50CA090388, P30CA016042, UCLA-0407058-01
- Status last verified
- Feb 2019
- First submitted
- 6 Jan 2005
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Phase II Clinical Trial of Combination Erlotinib (Tarceva®) and Fulvestrant (Faslodex®) Versus Erlotinib (Tarceva®) Alone in Advanced Non-Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT00100854
- Acronym / sponsor ID
- CDR0000407580
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Translational Oncology Research InternationalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Oct 2004 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 7 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of non-small cell lung cancer cells. Hormone therapy using fulvestrant may fight non-small cell lung cancer by lowering the amount of estrogen the body makes. Giving erlotinib together with fulvestrant may kill more tumor cells. It is not yet known whether giving erlotinib together with fulvestrant is more effective than erlotinib alone in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying giving erlotinib together with fulvestrant to see how well it works compared to erlotinib alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Compare objective tumor response in patients stage IIIB or IV non-small cell lung cancer treated with erlotinib hydrochloride with vs without fulvestrant.
Secondary
- Correlate response rate with ER and EGF receptor expression in patients treated with these regimens.
- Correlate measurement of ER-α, ER-β, EGF/HER-1 receptor and HER-2/neu receptor with clinical response in patients treated with these regimens.
- Correlate erlotinib hydrochloride resistance with ER and HER receptor expression in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status, gender, and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days.
- Arm II: Patients receive erlotinib hydrochloride as in arm I and fulvestrant intramuscularly on days 1, 15, and 29, and then every 28 days thereafter.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 30 days and then every 2 months until disease progression.
PROJECTED ACCRUAL: A total of 102 patients (34 in arm I and 68 in arm II) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Drug: erlotinib hydrochloridePatients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days. |
| Arm II | Experimental | Drug: erlotinib hydrochloride, Drug: fulvestrantPatients receive erlotinib hydrochloride as in arm I and fulvestrant intramuscularly on days 1, 15, and 29, and then every 28 days thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- adults over the age of 18 capable of giving informed consent.
- Histologically confirmed non-small cell lung cancer
- Stage IIIB or IV NSCLC
- Tumor tissue block available.
- ECOG performance status of 0, 1 or 2.
Key exclusion criteria (26 listed)
- Renal insufficiency (serum creatinine >2mg/dl)
- Liver insufficiency (serum total bilirubin >1.5X ULN, or serum transaminases > 2.5X the ULN or %X ULN if hepatic metastases).
- hematologic abnormality platelets< 100,000 ANC <1,500/mm3
- THerapeutic anticoagulation will be allowed, but patients receiving fulvestrant while on therapeutic anticoagulation will have the fulvestrant dose divided into twice as many syringes to minimize the volume of intramuscular injection in these patients. In patients receiving low molecular weight heparin or fondaparinux, these medications should be held for 12 hours before and after fulvestrant injection if possible.
- Active CNS metastases.
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 |
|---|---|---|
| erlotinib hydrochlorideGiven orally | Drug | Arm I, Arm II |
| fulvestrantGiven intramuscularly | Drug | Arm II |
Primary outcome
Objective tumor response
Time frame: 30 days
1 secondary outcome
Correlation of response rate with receptor expression
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Edward Garon, MD principal investigator
Jonsson Comprehensive Cancer 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 erlotinib hydrochloride and fulvestrant in people with Lung Cancer, run by Translational Oncology Research International 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 11 inclusion and 26 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: finished, as of the sponsor's last update on 5 Mar 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective tumor response (time frame: 30 days). 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 5 Mar 2019.