A Phase I Trial Using RAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer
- Most patients receiving treatment for head and neck cancer will develop difficulty
swallowing food and drinking liquids during the course of therapy. For this reason, it
will be recommended that a PEG (percutaneous endoscopic gastrostomy) tube be placed in
the participants stomach prior to undergoing the study regimen. This is to help
maintain weight and nutritional health.
- Since we are looking for highest dose of the study drug that can be administered safely
without severe or unmanageable side effects, not everyone who participates will receive
the same dose of RAD001 or cisplatin.
- The study regimen will last for seven weeks. During each week of study participation
the following will occur: Radiation will be administered each weekday (5 days per
week). Cisplatin will be given intravenously at the start of each week. RAD001 will be
given to the participant to take at home. Participants will take the study drug once a
day in the morning starting on day 1.
- A history and physical exam will be performed weekly while participant's are receiving
radiation treatment. Blood tests for routine laboratory testing will be performed
- Each month for the first two months after participants finish radiation therapy and
stop taking RAD001 and cisplatin, they will have a physical ezam, a neurologic exam,
and blood tests. X-rays, a CT, MRI and/or PET scans will also be performed a the two
month visit. After the first two months, follow-up will continue every 1-2 months for
the first year. Additionally, every 6 months for the first two years, follow-up visits
will include an assessment of speech and swallowing functions along with X-rays, CT,
MRI and/or PET scans.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the maximum tolerated dose (MTD) and safety of the RAD001 in combination with weekly cisplatin and radiation in patients with locally advanced HNSCC.
Jochen Lorch, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|