This Phase 1, single-site, dose-escalation study is being conducted to determine the maximum tolerated dose (MTD) of RAD001 as part of a specified combination regimen.
This Phase 1, single-site, dose-escalation study is being conducted to determine the MTD of RAD001 as part of a specified combination regimen. The combination regimen will be standard field whole pelvic RT in combination with cisplatin at 40mg/m2 weekly with RAD001 at dose escalation daily starting at 5 mg qod, then 5 mg qd, then 10 mg qd during the period of whole pelvic radiation therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
RAD001 will be administered orally as 5 mg qod, 5 mg qd, or 10mg qd continuously from study Day 1 until the end of whole pelvic radiation therapy unless the patient develops progression of disease or unacceptable toxicity prior to that.
Cisplatin will be administered intravenously once weekly at 40mg/m2 for 6 weeks. The preferred administration day is Monday.
Patients will receive 180 cGy daily fraction Monday through Friday x 25 days (4500 cGy total) using a four field technique throughout the entire treatment with all fields treated each day.
To determine the maximum tolerated dose for RAD001 as adjunct therapy to standard upfront treatment of advanced stage cervical cancer in combination with weekly cisplatin and whole pelvic external beam radiation
Time frame: every 7 days
To determine the dose limiting toxicities for RAD001 as adjunct therapy to standard upfront treatment of advanced stage cervical cancer in combination with weekly cisplatin and whole pelvic external beam radiation
Time frame: every 7 days
To determine the pharmacokinetics of RAD001 given as adjunct therapy to standard upfront treatment of advanced stage cervical cancer
Time frame: day 1 and day 15 during study treatment
To evaluate the pharmacogenetics of RAD001 in the specified patient population
Time frame: day 1 prior to starting study treatment
To evaluate microvessel density pre-and post-treatment with the specified treatment regimen in the specified patient population
Time frame: day 1 and end of treatment
To evaluate potential correlations between biomarkers HIF-1a, TSP-1, P53, VEGF, and VEGFR and use of the specified treatment regimen in the specified patient population
Time frame: day 1 and end of treatment
To evaluate progression free survival in the specified patient population
Time frame: from the time of treatment start until progression or up to 5 years after completion of study treatment
To assess quality of life as indicated by the Patient Care Monitor in the specified patient population
Time frame: every 7 days during study treatment
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