Study of Perifosine + Capecitabine for Colon Cancer Patients

This study has been completed.

Sponsor:

Collaborator:

Sarah Cannon Research Institute

Information provided by (Responsible Party):

AEterna Zentaris

ClinicalTrials.gov Identifier:

NCT01048580

First received: January 9, 2010

Last updated: February 27, 2013

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 9, 2010

Last Updated Date

February 27, 2013

Start Date ^ICMJE

October 2009

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety. Determination of maximum tolerated dose. [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01048580 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Perifosine + Capecitabine for Colon Cancer Patients

Official Title ^ICMJE

A Phase I Study of Perifosine + Capecitabine for Patients With Advanced Colon Cancer

Brief Summary

This is a Phase I study of Perifosine + Capecitabine for patients with advanced colon cancer.

Detailed Description

This study is a Phase I trial. A total of 3 ‐ 9 patients will be enrolled. Three patients will initially be enrolled. There will be no dose escalation in this study as only one dose for perifosine (50 mg) in combination with one dose of capecitabine (1000 mg/m2 BID) will be evaluated. The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients experienced DLT attributable to the study drug(s), when at least six patients have been treated at that dose and are evaluable for toxicity. Pharmacokinetic (PK) data will also be evaluated from all enrolled patients.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Colon Cancer

Intervention ^ICMJE

Drug: Perifosine + Capecitabine

Perifosine 50 mg qd + Capecitabine 1000 mg/m2 BID x 14 days

Other Name: Xeloda

Study Arm (s)

Experimental: Arm 1

Perifosine 50 mg qd + Capecitabine 1000 mg/m2 BID x 14 days

Intervention: Drug: Perifosine + Capecitabine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with 3rd line or > metastatic colon cancer
Patients must have received or not be candidates for regimens containing 5‐ FU, oxaliplatin, irinotecan, bevacizumab, and cetuximab or panitumumab
No prior exposure to perifosine
Adequate bone marrow, liver, and renal function
Patients must have at least one measurable lesion
Patients must agree to have extra blood drawn for PK analyses

Exclusion Criteria:

Patients with prior exposure to perifosine.
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).
Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5‐FU.
Patients with known central nervous system CNS metastases.
Patients with known HIV, Hepatitis B, or Hepatitis C seropositivity.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Association class II‐IV congestive heart failure.
Female patients who are pregnant or lactating are ineligible.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01048580

Other Study ID Numbers ^ICMJE

Perifosine 141

Has Data Monitoring Committee

Responsible Party

AEterna Zentaris

Study Sponsor ^ICMJE

AEterna Zentaris

Collaborators ^ICMJE

Sarah Cannon Research Institute

Investigators ^ICMJE

Study Chair:

Johanna Bendell,, MD

Sarah Cannon Research Institute

Information Provided By

AEterna Zentaris

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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