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

Phase 1
18 Years
Not Enrolling
Colon Cancer

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Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Safety. Determination of maximum tolerated dose.

Outcome Time Frame:

Every 3 weeks

Safety Issue:


Principal Investigator

Johanna Bendell,, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:

Perifosine 141



Start Date:

October 2009

Completion Date:

October 2011

Related Keywords:

  • Colon Cancer
  • Perifosine
  • Capecitabine
  • Colon Cancer
  • Colonic Neoplasms