Status:
COMPLETED
Placebo-Controlled Study of Perifosine + Single Agent Chemotherapy for Metastatic Cancer Patients
Lead Sponsor:
AEterna Zentaris
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. The study is subsequently closed to enrollment in all arms except patients wi...
Detailed Description
This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. If there is any evidence of improved time to progression in any tumor type wi...
Eligibility Criteria
Inclusion
- In the opinion of the treating physician, treatment with one of the following regimens should represent an appropriate treatment for the patient.
- \- Capecitabine 825 mg/m2 BID days 1 - 14 q 3 weeks
- Patients should have a histologically or cytologically confirmed diagnosis of colorectal cancer.
- Patients must have received at least one but no more than two prior chemotherapy regimen(s) for the treatment of metastatic or recurrent disease.
- ECOG performance status 0 or 1.
- Leukocytes \>= 4,000/μL
- absolute neutrophil count \>= 1,500/ μL
- platelets \>= 100,000/ μL
- HCT \> 28% (with or without growth factor support)
- Creatinine \<= 2.5 mg/dl
- total bilirubin \< 1.5 x upper limit of normal
- transaminase \< 2.5 x upper limit of normal
- Patients must have recovered from acute toxicity-excluding alopecia-related to prior therapy, including surgery or radiotherapy.
- Patients with brain metastases may be admitted, provided the disease has been treated and been stable for 2 months.
- Patients must have ability to understand and the willingness to sign a written informed consent document.
Exclusion
- 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).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, psychiatric illness, or social situations that would limit compliance with study requirements.
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study due to potential pharmacokinetic interactions with perifosine.
- Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Assoc. class II - IV congestive heart failure.
- Female patients who are pregnant or lactating are ineligible.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT00398879
Start Date
August 1 2005
End Date
October 1 2011
Last Update
March 14 2018
Active Locations (49)
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1
AOI Pharmaceuticals Investigative Site
Tucson, Arizona, United States, 85704
2
AOI Pharmaceuticals Investigative Site
Beverly Hills, California, United States, 90211
3
AOI Pharmaceuticals Investigative Site
Deer Park, California, United States, 94574
4
AOI Pharmaceuticals Investigative Site
Monterey, California, United States, 93940