Phase II Study of Perifosine for Patients With Metastatic Carcinoma of the Kidney Who Have Progressed on a VEGF Receptor Inhibitor
This is a Phase II study. Patients with kidney carcinoma will be considered in two groups.
Patients in group A will have previously failed a VEGF receptor inhibitor but not an mTOR
inhibitor, while patients in group B will have failed both a VEGF receptor inhibitor and an
mTOR inhibitor. Evaluation of each group will be performed separately. The goals of this
1. To measure clinical benefit defined as an objective tumor response using RESIST or
progression-free survival for more than 12 weeks in patients with metastatic carcinoma
of the kidney who have failed or have progressed on a VEGF receptor inhibitor
2. To evaluate the safety of perifosine in patients with metastatic carcinoma of the
kidney who have failed or have progressed on a VEGF receptor inhibitor.
Treatment Phase/duration of treatment: All patients will be treated with daily perifosine
at 100 mg PO daily until tumor progression (by the RECIST criteria) or unacceptable
toxicity. Once radiological disease progression has been documented by the treating
physician, the patient will go off study. Patients are encouraged to have two measurements
for confirmation of progression.
Follow-Up Phase: All patients will be followed-up for SAEs until at least 30 days after
discontinuation of perifosine. All patients who are discontinued from perifosine for any
reason other than disease progression will continue to have tumor assessments until the
patient has documented disease progression or has begun other therapies.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response using RESIST OR progression-free survival
Nicholas J Vogelzang, MD
Nevada Cancer Institute
United States: Food and Drug Administration
|Investigative Site||Nyack, New York|
|Investigative Site||Louisville, Kentucky 40202|
|Investigative Site||Morristown, New Jersey 07962|