A Phase 1 Trial of the Combination of Perifosine and Paclitaxel Given Either Weekly or Every 3 Weeks
This is a phase 1, open-label trial of perifosine and paclitaxel administered either weekly
or every 3 weeks in patients with malignancies for whom single agent paclitaxel is a
reasonable treatment option. All patients will receive paclitaxel either at a dose of 80
mg/m2 on days 1, 8 and 15 of a 28-day cycle (Arm A) or at 175 mg/m2 administered on day 8 of
a 21 day cycle (Arm B). Patients on both arm A and arm B will receive premedication with
diphenhydramine 50 mg IV 30 minutes prior to treatment; ranitidine 50 mg IV 30 minutes prior
to treatment and dexamethasone 20 mg IV at 30 minutes prior to treatment. The 1st cohort of
patients on Arm A will receive perifosine orally at a dose of 50 mg per day for the first 21
days of the 28-day cycle and on Arm B will receive perifosine orally at a dose of 50 mg per
day for the first 14 days of the 21-day cycle. On each arm, the perifosine dose will be
escalated in subsequent groups to 50 mg bid and then 50 mg tid as tolerated. (See below)
Alternating cohorts of 3 patients will be entered first to Arm A and then to Arm B. The
perifosine dose escalation for Arm A and Arm B will be performed separately according to the
following algorithm. For each arm, a maximum tolerated dose (MTD) will be defined as a dose
that can be given without grade 3/4 non-hematologic toxicity in more than 1/3 patients. If
2/3 patients in any cohort encounter a grade 3/4 non-hematologic toxicity, an additional 3
patients will be added. If the dose is intolerable for >3/6 patients then the previous dose
level will be declared the MTD for that arm.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
GI Toxicities
3 months
Yes
United States: Food and Drug Administration
Perifosine 104
NCT00399126
November 2004
October 2011
Name | Location |
---|---|
AOI Pharmaceuticals Investigative Site | Chattanooga, Tennessee 37404 |