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This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. RAD001 will be administered orally at a dose of 10 mg daily.
Full description
This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. Patients may have received up to 2 prior chemotherapy regimens for small cell lung carcinoma, but no prior therapy with an m-TOR inhibitor. RAD001 will be administered orally at a dose of 10 mg daily. A cycle will be defined as 3 weeks of study drug administration, and patients will have tumor measurements every 2 cycles. Study participation will continue until disease progression or intolerable toxicities. In addition, in patients who consent, archival tumor tissue (paraffin block from original biopsy) will be collected for research purposes.
Enrollment
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Inclusion criteria
Cytologically or histologically confirmed small cell carcinoma of the lung that has progressed post first-line therapy. Mixed small and non-small cell tumors are excluded.
Prior chemotherapy for small cell carcinoma. Up to 2 prior chemotherapy regimens for small cell lung carcinoma are allowed. No prior therapy with an m-TOR inhibitor (e.g. CCI-779).
Unidimensionally measurable disease (RECIST criteria). If the only site of measurable disease is in a previously irradiated area, the patient must have documented progression of disease in this area.
ECOG performance status 0-2.
A minimum of 4 weeks should elapse from prior chemotherapy. Patients must have fully recovered from the effects of any prior surgery or radiation therapy or other anticancer therapies, including immunotherapy and investigational agents.
No progressive brain metastases. Brain metastases should have been previously treated with surgery and/or radiation.
Patients with a prior malignancy should have at least 3 years of disease-free survival. Prior curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer or other in situ malignancies are allowed.
No other coexisting medical condition that would preclude full compliance with the study.
Required laboratory values (obtained < 1 week prior to enrollment):
Age >/= 18 years and capacity to give informed consent.
Patients should be advised to discontinue drugs that interact with CYP3A4 (see list of examples in Table 3.1 of the full protocol), if medically safe.
All patients must have given signed, informed consent prior to registration on study.
Exclusion criteria
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40 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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