A Pilot Study of Erlotinib and Temsirolimus in Patients with Advanced Non-small Cell Lung Cancer After Failure of at Least 1 Prior Platinum-based Treatment
- Conditions
- SCLC
- Registration Number
- EUCTR2009-017101-11-AT
- Lead Sponsor
- MUW, Klinik für Innere Medizin I, Onkologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
•Histologically or cytologically confirmed stage IIIB or IV NSCLC.
•Measurable disease according to RECIST Criteria 1.1 11
•Relapsed or progressed after treatment with 1 or 2 (no more than 2) prior chemotherapy regimens (with or without bevacizumab), at least 1 of which must have been a platinum-based treatment. Patients may not have received investigational therapy as their only prior therapy.
•Recovered from the toxic effects of prior therapy.
•Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
•At least 18 years of age.
•Adequate hematologic function as defined by: white blood cell (WBC) count = 2500 cells/µL; absolute neutrophil count (ANC) = 1500 cells/µL; platelet count = 100,000/µL; adequate hepatic, and renal function within 7 days prior to randomisation as defined by serum creatinine < 1.5 x the upper limit of normal (ULN) 1; total bilirubin < 1.5 x ULN; AST and ALT < 3 x ULN (if clearly attributable to liver metastases, = 5 x ULN is permitted).
•Fasting serum cholesterol < 2.0 x ULN (therapy permitted), fasting serum triglycerides < 2.0 x ULN (therapy permitted), fasting glycosolated hemoglobin A1c (HbA1c) < 9 % (therapy permitted)
•Women of childbearing potential must be practicing a medically acceptable contraceptive regimen and must have a negative serum pregnancy test within 14 days prior to inclusion. Patients who are postmenopausal for at least 1 year (> 12 months since last menses) or are surgically sterilized do not require this test.
•Men who are not surgically sterile must be practicing a medically safe and effective contraceptive regimen from the time of study inclusion, and agree to continue practicing until at least 90 days after the last administration of study treatment.
•Accessible for repeat dosing and follow-up.
•Life expectancy of greater than 12 weeks.
•Given written informed consent (IC).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Active concurrent primary malignancy (except non-melanoma skin cancer or in situ carcinoma of the cervix). If there is a history of prior malignancy, the patient must be disease-free for at least 5 years.
•Use of any investigational drugs, biologics, or devices within 4 weeks prior to inclusion.
•Patients who have had chemotherapy or radiotherapy within 4 weeks prior to inclusion.
•Previous exposure to temsirolimus or erlotinib (or other TKIs).
•Women who are pregnant or breastfeeding.
•Not recovered from uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
•Uncontrolled hypertension.
•Known HIV-positive status.
•Treatment with vitamin K antagonists
•Active smokers (currently smoking more than one cigarette per day for at least one year)*
•Concomitant treatment with strong CYP3A4 inhibitors or inducers
•Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required.
•Patients with known hypersensitivity reactions to Torisel® or Tarceva®
•Patients with known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin and azithromycin)
* as smoking is known to reduce exposure to erlotinib.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method