- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00399087
Phase I Trial of Docetaxel With Perifosine
February 12, 2014 updated by: AEterna Zentaris
A Phase 1 Trial of the Combination of Perifosine and Docetaxel With or Without Prednisone
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
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Johnson City, Tennessee, United States, 37604
- Investigative Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Patients must have histologically or cytologically confirmed diagnosis of cancer for which treatment with single agent docetaxel would be an appropriate treatment option.
- At least 18 years of age.
- Patients may be currently receiving docetaxel using the schedule in the protocol, as long as the treating investigator has reasonable expectation that the patient will continue to receive docetaxel for 2 or more additional cycles. The current regimen does not count towards the 2 regimens as long as the patient is not progressing on therapy..
- Patients must have a life expectancy of more than 3 months.
- Patients must have a performance status of 0 to 2 according to the ECOG criteria.
- Patients must have normal organ and marrow function as defined in the protocol: leukocytes >=4,000/microL, absolute neutrophil count >=1,500/microL, platelets >=100,000/microL, HCT > 28%, total bilirubin < 1.5 x upper limit of normal, AST (SGOT)/ALT (SGPT) <=2.5 X institutional upper limit of normal, creatinine <= 2.5 mg/dl
- Patients must have recovered from acute toxicity related to prior therapy, excluding alopecia, including surgery or radiotherapy.
- Patients must be able to ingest oral medications.
- Female patients who are pregnant or lactating are ineligible. All females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment. Men and women of childbearing potential must agree to employ adequate contraception to prevent pregnancy while on therapy and for four weeks after the completion of treatment.
- Patients must have ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- Patients may not be receiving any other investigational agents or devices.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with perifosine.
- Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Assoc. class II-IV congestive heart failure.
- Patients with a history of hypersensitivity reaction to products containing Polysorbate 80 (Tween 80).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Perifosine D1 + Docetaxel
|
Perifosine oral administration
IV administration
|
Experimental: Perifosine D1+ Docexatel+Prednisone
|
Perifosine oral administration
IV administration
Oral administration
|
Experimental: Perifosine+ D1,8 and 15+Docetaxel+Prednisone
|
Perifosine oral administration
IV administration
Oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease progression
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 24, No 18S (June 20 Supplement), 2006: 13066
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
November 10, 2006
First Submitted That Met QC Criteria
November 10, 2006
First Posted (Estimate)
November 14, 2006
Study Record Updates
Last Update Posted (Estimate)
February 13, 2014
Last Update Submitted That Met QC Criteria
February 12, 2014
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Docetaxel
- Prednisone
Other Study ID Numbers
- Perifosine 105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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