Clinical trial NCT01048580: Study of Perifosine + Capecitabine for Colon Cancer Patients
Official title: A Phase I Study of Perifosine + Capecitabine for Patients With Advanced Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colon Cancer
Keywords: Perifosine
Capecitabine
Colon Cancer
Lead sponsor: AEterna Zentaris
Sponsor class: INDUSTRY
Collaborators: name: SCRI Development Innovations, LLC
First posted: 2010-01-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Safety and tolerability of the combination of perifosine and capecitabine (i.e., dose limiting toxicity)
timeFrame: Every 3 weeks after dosing
Secondary outcomes:
measure: Best overall response
timeFrame: Every 3 cycles after dosing (length of one cycle is 21 days)
measure: Time to progression
timeFrame: Every 3 cycles after dosing (length of one cycle is 21 days)
measure: Pharmacokinetic (PK) data for the combination of perifosine and capecitabine
timeFrame: Up to cyle 5 no pharmacokinetic samples were obtained. Cycle 1/Day 11 until Cycle 4/Day 11: pharmacokinetic samples obtained 0.5, 1, 2, 4, 6 and 8 hours after dosing
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Johanna Bendell,, MD
role: STUDY_CHAIR
References:
citation: Journal of Oncology, 2010 ASCO Annual Meeting Abstracts. Vol. 28, No. 15_suppl (May 20Supplement), 2010:e14086