Non Small Cell Lung Carcinoma
Conditions
Keywords
Non Small Cell Lung Cancer, Stage IIIB, Stage IV, Stable on Erlotinib, Exhibit Positivity for Estrogen or Progesterone Receptor
Brief 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.
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.
Interventions
DRUGFulvestrant 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.
Sponsors
AstraZeneca
Lyudmila Bazhenova, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival | 14 weeks after start of fulvestrant |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | Patients will be followed until death |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fulvestrant and Erlotinib Single-arm study
Fulvestrant 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. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | patient ineligible (out of lab range) | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Fulvestrant and Erlotinib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Progression-free Survival
Time frame: 14 weeks after start of fulvestrant
Population: Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data were not collected for this Outcome Measure. Outcomes were not collected due to withdrawal of the funding. Data not available.
Secondary
Overall Survival
Time frame: Patients will be followed until death
Population: Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data were not collected for this Outcome Measure. Outcomes were not collected due to withdrawal of the funding. Data not available.