None listed
Conditions
Brief summary
Recent work has reflected importance of estrogen in causation of lung cancer. This is especially true for female population and non smokers. Present trial is designed to test the hypothesis that decreasing estrogen along with inhibiting nutrient pathway in cancer cells could lead to disease control. There is preliminary data to suggest that the combination might be useful for other patients as well. The other highlight of the study is the oral treatment in contrast to other treatments which are injectable chemotherapy.
Interventions
Patients with metastatic non small cell lung cancer who have previously failed on platinum based chemotherapy will be treated on a daily oral combination of letrozole 2.5 mg and everolimus 10mg. The patients will be assessed on a regular basis with CT-PET scan. The first assessment will be after 4 weeks. Subsequent scans will be at 8 weeks interval. Patients will continue the treatment till they are having benefit.
Sponsors
Dept of Medical Oncology, Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically proven diagnosis of non-small cell lung cancer of either gender. 2. Age > 18 years for males. Females should be post-menopausal, which is defined as:• Prior oopherectomy, or • 12 month-history of amenorrhoea, or • FSH (Follicle Stimulating Hormone) and LH (Luteinizing Hormone) in post-menopausal range. There is no upper age limit. 3. performance status = 2.4. Adequate organ function• Hematological- Hb> 90 g/L, Absolute Neutrophil Count = 1.5 x 109/L, platelets = 100 x 109/L.• Liver functions- bilirubin = 2 x upper limit normal (ULN), Aspartate Aminotransferase /Alanine Aminotransferase/ Alkaline Phosphatase = 2.5 x ULN or = 5 x ULN in presence of liver metastases, S. albumin = 30 g/L.• Renal function- Creatinine = 2 ULN, Creatinine clearance > 30 mL/min. 6. Patients should stop any hormonal medication as hormone replacement therapy or progesterone at least one month prior to enrolment. 7. Patients should have at least one measurable lesion by RECIST criteria.
Exclusion criteria
1. Untreated brain metastases. 2. Patients on strong inhibitor or inducer of isoenzyme CYP3A. 3. Serious co-morbidities such as severe cardiac failure or severe pulmonary compromise or severe and active infections. 4. Uncontrolled diabetes.5.Patients with grade 3 hypercholesterolemia / hypertriglyceridemia or = grade 2 hypercholesterolemia / hypertriglyceridemia with history of coronary artery disease (despite lipid lowering treatment if given)6. Previous treatment with mTOR inhibitors and/or known hypersensitivity to mTOR inhibitors.7. A known history of Human Immunodeficiency Virus or previous seropositivity for the virus.8. Leptomeningeal or uncontrolled brain metastases, including patients who continue to require glucocorticoids or intrathecal chemotherapy for brain or leptomeningeal metastases (documented by lumbar puncture).9. Patients will be excluded if they are on raloxifene or tamoxifen. 10. Patients who have an impairment of gastrointestinal function or who havegastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome).
Outcome results
None listed