Study of Perifosine + Capecitabine for Colon Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01048580
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : February 19, 2014
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
AEterna Zentaris

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

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: Perifosine + Capecitabine Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Perifosine + Capecitabine for Patients With Advanced Colon Cancer
Study Start Date : October 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
Perifosine 50 mg qd + Capecitabine 1000 mg/m2 BID x 14 days
Drug: Perifosine + Capecitabine
Perifosine 50 mg qd + Capecitabine 1000 mg/m2 BID x 14 days
Other Name: Xeloda

Primary Outcome Measures :
  1. Safety. Determination of maximum tolerated dose. [ Time Frame: Every 3 weeks ]

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01048580

Sponsors and Collaborators
AEterna Zentaris
SCRI Development Innovations, LLC
Study Chair: Johanna Bendell,, MD SCRI Development Innovations, LLC

Publications of Results:
Journal of Oncology, 2010 ASCO Annual Meeting Abstracts. Vol. 28, No. 15_suppl (May 20Supplement), 2010:e14086

Responsible Party: AEterna Zentaris Identifier: NCT01048580     History of Changes
Other Study ID Numbers: Perifosine 141
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: November 2011

Keywords provided by AEterna Zentaris:
Colon Cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents