- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01048580
Study of Perifosine + Capecitabine for Colon Cancer Patients
A Phase I Study of Perifosine + Capecitabine for Patients With Advanced Colon Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Perifosine +Capecitabine
One cycle of therapy will be defined as 3 weeks (21 days).
Perifosine 50 mg qd (Days 1-21) + Capecitabine 1000 mg/m2 BID (Days 1-14).
|
Perifosine 50 mg orally once a day (Days 1-21)
Other Names:
Capecitabine 1000 mg/m2 orally twice per day (Days 1-14)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of the combination of perifosine and capecitabine (i.e., dose limiting toxicity)
Time Frame: Every 3 weeks after dosing
|
The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients experienced dose limiting toxicity (DLT) attributable to the study drug(s), when at least six patients were treated at that dose and are evaluable for toxicity. A DLT will be defined as any of the following deemed to be related to study drug(s):
|
Every 3 weeks after dosing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best overall response
Time Frame: Every 3 cycles after dosing (length of one cycle is 21 days)
|
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response Evaluation Criteria in solid tumors (RECIST): Measurable disease is defined as the presence of at least one measurable lesion. Measurable lesions are lesions that can be accurately measured in at least one dimension and fit one of the following criteria:
|
Every 3 cycles after dosing (length of one cycle is 21 days)
|
Time to progression
Time Frame: Every 3 cycles after dosing (length of one cycle is 21 days)
|
This is the interval from the initiation of treatment to the time of documented, objective progression using the same methods of evaluation that were used at baseline. In order for a patient to be regarded as having progressive disease, the following criteria must be met:
|
Every 3 cycles after dosing (length of one cycle is 21 days)
|
Pharmacokinetic (PK) data for the combination of perifosine and capecitabine
Time Frame: 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
|
PK data will also be evaluated from all enrolled patients.
PK analyses will present peak plasma concentrations (Cmax) as well as Area under the plasma concentration verus time curve (AUC).
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Johanna Bendell,, MD, SCRI Development Innovations, LLC
Publications and helpful links
General Publications
- Journal of Oncology, 2010 ASCO Annual Meeting Abstracts. Vol. 28, No. 15_suppl (May 20Supplement), 2010:e14086
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Colonic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
Other Study ID Numbers
- Perifosine 141
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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