Phase I Trial of Paclitaxel With Perifosine

Neoplasms Clinical Trial

Official title: A Phase 1 Trial of the Combination of Perifosine and Paclitaxel Given Either Weekly or Every 3 Weeks

Status Completed

Clinical Trial Summary

This is a study of the drug perifosine given in combination with paclitaxel. Perifosine is an oral anti-cancer agent that has been used in more than 140 people. Paclitaxel is a standard chemotherapy agent used in many types of cancer. This study is designed to determine the highest dose of perifosine that can be administered to people every day while they are receiving paclitaxel in one of two regimens, without severe or prolonged nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day.

Clinical Trial Description

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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

• NCT number: NCT00399126
• Study type: Interventional
• Source: AEterna Zentaris
• Status: Completed
• Phase: Phase 1
• Start date: November 2004
• Completion date: October 2011