Study of Perifosine + Capecitabine for Colon Cancer Patients

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AEterna Zentaris
• Collaborator: SCRI Development Innovations, LLC
• Treatments: Capecitabine

Criteria

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.