NCT00399087

Phase I Trial of Docetaxel With Perifosine

A Phase 1 Trial of the Combination of Perifosine and Docetaxel With or Without Prednisone

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: AEterna Zentaris · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study of the drug perifosine given in combination with docetaxel. Perifosine is an oral anti-cancer agent that has been used in more than 140 people. Docetaxel 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 docetaxel with or without a steroid called prednisone, without severe or prolonged nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day.

Detailed description

This is a phase 1, open-label trial of perifosine and docetaxel with or without prednisone in patients with malignancies for whom single agent docetaxel is a reasonable treatment option. All patients will receive docetaxel at a dose of 75 mg/m2 on day 8 of a 21-day cycle either without (Arm A) or with prednisone 5 mg bid on days 1 - 21 (Arms B and C). (Patients on all arms will receive premedication with dexamethasone around the time of docetaxel administration either as described in the product insert for arm A or as used in prior prostate cancer phase III studies for arm B and C. The 1st cohort of patients on Arm A and 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. Alternating cohorts of 3 patients will be entered first to Arm A and then to Arm B. At the completion of arms A and B, 3 cohorts of patients will be entered who will receive perifosine weekly at doses of 900, 1200 and 1500 mg. The total dose will be divided into 300 mg doses which will be delivered at least 4 hours apart. The perifosine dose escalation for each arm 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.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	Perifosine	Perifosine oral administration
DRUG	Docetaxel	IV administration
DRUG	Prednisone	Oral administration

Timeline

• Start date: 2004-11-01
• Primary completion: 2010-01-01
• Completion: 2011-01-01
• First posted: 2006-11-14
• Last updated: 2014-02-13

Locations

1 site across 1 country: United States