Stage IV Breast Cancer Clinical Trial
Official title:
Phase II Evaluation of Real-Time, Pharmacokinetically Guided Everolimus in Patients With Hormone Receptor Positive Breast Cancer, Pancreatic Neuroendocrine Tumors (PNET), and Renal Cell Carcinoma
This phase II trial studies how well real-time pharmacokinetic therapeutic drug monitoring works in preventing stomatitis from developing in patients with hormone receptor positive breast cancer, pancreatic neuroendocrine tumors, or kidney cancer that are receiving a type of cancer drug called everolimus. Stomatitis is a common side effect of everolimus that causes inflammation of the mouth, with or without oral ulcers, and frequently leads to patients discontinuing the medication. Monitoring the blood levels of everolimus and making adjustments in a patient's dose may be able to decrease the incidence of stomatitis, while maintaining the effectiveness of everolimus to treat the cancer.
PRIMARY OBJECTIVE:
To determine frequency of any grade of stomatitis at day 29 (cycle 2, day 1) in patients
receiving dose-adjusted everolimus.
SECONDARY OBJECTIVES:
1. Progression-free survival rates at 6 months.
2. Pharmacodynamic (PD)-inhibition of downstream mammalian target of rapamycin (mTOR)
effectors in peripheral blood.
3. Number of dose adjustments required.
4. Percentage of days on therapy.
5. Average minimum concentration (Cmin) values.
6. Frequency and type of treatments for stomatitis.
7. Genetic predictors of stomatitis development in selected outlier patients.
OUTLINE:
Patients receive everolimus orally (PO) daily on days 1-28. Treatment repeats every 28 days
for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients
also undergo real-time pharmacokinetic therapeutic drug monitoring (TDM) on days 4, 8, and
15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary.
If the everolimus dose is adjusted, patients will continue to undergo real-time
pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures.
Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day
1 of courses 2-6.
After completion of study treatment, patients are followed up every 12 weeks.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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