Phase I Trial of Docetaxel With Perifosine

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: Perifosine; Drug: Docetaxel; Drug: Prednisone

• Registration Number: NCT00399087
• Lead Sponsor: AEterna Zentaris

Brief 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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2006-11-10
• Study First Submitted QC: 2006-11-10
• Study First Posted: 2006-11-14
• Primary Completion: 2010-01
• Study Completion: 2011-01
• Status Verified: 2013-02
• Last Update Submitted: 2014-02-12
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perifosine+ D1,8 and 15+Docetaxel+Prednisone	Docetaxel	-
Perifosine D1 + Docetaxel	Perifosine	-
Perifosine D1+ Docexatel+Prednisone	Perifosine	-
Perifosine D1 + Docetaxel	Docetaxel	-
Perifosine D1+ Docexatel+Prednisone	Docetaxel	-
Perifosine D1+ Docexatel+Prednisone	Prednisone	-
Perifosine+ D1,8 and 15+Docetaxel+Prednisone	Prednisone	-
Perifosine+ D1,8 and 15+Docetaxel+Prednisone	Perifosine	-

Primary Outcome Measures

Name	Time	Method
Safety	3 years

Secondary Outcome Measures

Name	Time	Method
Disease progression	3 years

Trial Locations

Locations (1)

Investigative Site; 🇺🇸 Johnson City, Tennessee, United States