Placebo-Controlled Study of Perifosine + Single Agent Chemotherapy for Metastatic Cancer Patients - Full Text View

Purpose

This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. The study is subsequently closed to enrollment in all arms except patients with metastatic colorectal cancer which would be randomized to either capecitabine plus perifosine or capecitabine alone.

The effects of perifosine may be manifested by increased time to progression, tumor regression reflected in partial or complete responses, or a combination of these outcomes. The primary goal of this trial is to obtain a preliminary and objective assessment of the effects of perifosine on time to progression.

Condition	Intervention	Phase
Colon Cancer	Drug: Perifosine in combination with capecitabine	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment
Official Title:	A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients

Resource links provided by NLM:

Drug Information available for: Capecitabine

U.S. FDA Resources

Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:

To determine the time to tumor progression. [ Time Frame: Every 12 weeks ]

Secondary Outcome Measures:

To determine the toxicity of single agent chemotherapy in combination with perifosine [ Time Frame: Every 12 weeks ]
To compare the time to progression of chemotherapy in combination with placebo to historical experience [ Time Frame: Every 12 weeks ]


Enrollment:	381
Study Start Date:	August 2005
Study Completion Date:	October 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Perifosine 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression	Drug: Perifosine in combination with capecitabine Perifosine or Placebo 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks Other Names: Perifosine Capecitabine
Placebo Comparator: 2 Perifosine Placebo 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression	Drug: Perifosine in combination with capecitabine Perifosine or Placebo 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks Other Names: Perifosine Capecitabine

Detailed Description:

This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. If there is any evidence of improved time to progression in any tumor type with any of the drugs to be evaluated, the initial study or component(s) of the study will be expanded to increase the certainty that this is an effect of perifosine. If there is compelling evidence of benefit from this study, a phase 3 trial will be conducted to obtain proof of principle.

Primary Study Objectives:

To determine the time to tumor progression when receiving single agent chemotherapy (capecitabine) in combination with perifosine in comparison to patients receiving single agent chemotherapy (capecitabine) alone (i.e., with placebo).

Secondary Study Objectives:

To determine the toxicity of single agent chemotherapy in combination with perifosine.
To compare the time to progression of chemotherapy in combination with placebo to historical experience.
Overall survival will also be evaluated.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

In the opinion of the treating physician, treatment with one of the following regimens should represent an appropriate treatment for the patient.

- Capecitabine 825 mg/m2 BID days 1 - 14 q 3 weeks
Patients should have a histologically or cytologically confirmed diagnosis of colorectal cancer.
Patients must have received at least one but no more than two prior chemotherapy regimen(s) for the treatment of metastatic or recurrent disease.
ECOG performance status 0 or 1.
- Leukocytes >= 4,000/μL
- absolute neutrophil count >= 1,500/ μL
- platelets >= 100,000/ μL
- HCT > 28% (with or without growth factor support)
- Creatinine <= 2.5 mg/dl
- total bilirubin < 1.5 x upper limit of normal
- transaminase < 2.5 x upper limit of normal
Patients must have recovered from acute toxicity—excluding alopecia—related to prior therapy, including surgery or radiotherapy.
Patients with brain metastases may be admitted, provided the disease has been treated and been stable for 2 months.
Patients must have ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients 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, psychiatric illness, or social situations that would limit compliance with study requirements.
HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study due to potential 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.
Female patients who are pregnant or lactating are ineligible.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398879

Show 49 Study Locations

Sponsors and Collaborators

AEterna Zentaris

More Information

Publications:

Bendell JC, Nemunaitis J, Vukelja SJ, Hagenstad C, Campos LT, Hermann RC, Sportelli P, Gardner L, Richards DA. Randomized placebo-controlled phase II trial of perifosine plus capecitabine as second- or third-line therapy in patients with metastatic colorectal cancer. J Clin Oncol. 2011 Nov 20;29(33):4394-400. doi: 10.1200/JCO.2011.36.1980. Epub 2011 Oct 3.


Responsible Party:	AEterna Zentaris
ClinicalTrials.gov Identifier:	NCT00398879 History of Changes
Other Study ID Numbers:	Perifosine 211
Study First Received:	November 6, 2006
Last Updated:	March 4, 2013

Keywords provided by AEterna Zentaris:


Capecitabine

Additional relevant MeSH terms:


Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes Capecitabine	Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

ClinicalTrials.gov processed this record on May 25, 2017