Lung Cancer – NCI-08-C-0078
Dr. Phillip A. Dennis
Principal Investigator
NCI’s Center for Cancer Research (CCR) is currently conducting the following trial for patients with non-small cell lung cancer. Click on the trial below for additional details, including a summary of primary eligibility, study outline, and information on how to contact Dr. Dennis and his staff directly.
You may also call the Clinical Trials Referral Office at 1-888-NCI-1937 (1-888-624-1937) to inquire about referring a patient to this trial.
This is a Phase I followed by a Phase II study.
- Tumor tissue will be obtained at baseline and after two cycles of therapy or at time of progression, whichever occurs first:
- For the Phase I portion, patients can provide fixed tissue from any time point for baseline, and subsequent biopsies are optional
- For the Phase II portion, fixed tissue for baseline must be from a time point after the most recent chemotherapy
- All patients will have pathway analysis using peripheral blood mononuclear cells at baseline; at Day 8; and at every two cycles of therapy or at time of progression, whichever occurs first
- Patients will receive sirolimus for 7 days prior to the initiation of pemetrexed
- Patients receive a daily dose of folic acid orally and B12 subcutaneously/intramuscularly every 21 days starting 5 to 7 days before the first dose of pemetrexed
- Patients receive a 21-day cycle of intravenous (IV) pemetrexed starting on Day 8
- Patients receive oral dexamethasone twice daily (the day before, the day of, and the day after the administration of pemetrexed)
Why is this trial important?
Lung cancer is a leading cause of cancer mortality because it is often diagnosed late, and is associated with resistance to chemotherapy. The mTOR pathway, responsible for cell proliferation and survival, is often activated in lung cancer and may contribute to drug resistance. Sirolimus is an FDA-approved drug for preventing transplant rejection that is known to block the mTOR pathway. Pemetrexed is an FDA-approved drug with a 9% response rate in relapsed lung cancer. By combining sirolimus with pemetrexed, we might be able to obtain an improvement in the response rate and offer people with relapsed lung cancer a better chance of response to chemotherapy.
Back to Top
