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Study of Perifosine + Capecitabine for Colon Cancer Patients

Primary Purpose

Colon Cancer

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Perifosine
Capecitabine
Sponsored by
AEterna Zentaris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Perifosine, Capecitabine, Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Perifosine +Capecitabine

    Arm Description

    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).

    Outcomes

    Primary Outcome Measures

    Safety and tolerability of the combination of perifosine and capecitabine (i.e., dose limiting toxicity)
    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): Grade 3 non-hematologic toxicity except alopecia not reversible to Grade 2 or less within 96 hours Any Grade 4 toxicity DLT will be based on the first cycle of treatment (first 21 days). Toxicity will be graded according to the NCI CTCAE version 3.0. To be evaluable for toxicity, a patient must receive at least 1 complete course of treatment or have experienced DLT.

    Secondary Outcome Measures

    Best overall response
    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: Longest diameter ≥ 20 mm using conventional techniques, or ≥ 10 mm with spiral CT scan.
    Time to progression
    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: The site of disease must have been evaluated either at baseline or while receiving study medication. Both evaluations must use the same methodology. PET scan results will not be used as evidence of either progression or response..
    Pharmacokinetic (PK) data for the combination of perifosine and capecitabine
    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).

    Full Information

    First Posted
    January 9, 2010
    Last Updated
    June 26, 2018
    Sponsor
    AEterna Zentaris
    Collaborators
    SCRI Development Innovations, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01048580
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AEterna Zentaris
    Collaborators
    SCRI Development Innovations, LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colon Cancer
    Keywords
    Perifosine, Capecitabine, Colon Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Perifosine +Capecitabine
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    Perifosine
    Other Intervention Name(s)
    D-21266, KRX-0401
    Intervention Description
    Perifosine 50 mg orally once a day (Days 1-21)
    Intervention Type
    Drug
    Intervention Name(s)
    Capecitabine
    Other Intervention Name(s)
    Xeloda
    Intervention Description
    Capecitabine 1000 mg/m2 orally twice per day (Days 1-14)
    Primary Outcome Measure Information:
    Title
    Safety and tolerability of the combination of perifosine and capecitabine (i.e., dose limiting toxicity)
    Description
    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): Grade 3 non-hematologic toxicity except alopecia not reversible to Grade 2 or less within 96 hours Any Grade 4 toxicity DLT will be based on the first cycle of treatment (first 21 days). Toxicity will be graded according to the NCI CTCAE version 3.0. To be evaluable for toxicity, a patient must receive at least 1 complete course of treatment or have experienced DLT.
    Time Frame
    Every 3 weeks after dosing
    Secondary Outcome Measure Information:
    Title
    Best overall response
    Description
    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: Longest diameter ≥ 20 mm using conventional techniques, or ≥ 10 mm with spiral CT scan.
    Time Frame
    Every 3 cycles after dosing (length of one cycle is 21 days)
    Title
    Time to progression
    Description
    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: The site of disease must have been evaluated either at baseline or while receiving study medication. Both evaluations must use the same methodology. PET scan results will not be used as evidence of either progression or response..
    Time Frame
    Every 3 cycles after dosing (length of one cycle is 21 days)
    Title
    Pharmacokinetic (PK) data for the combination of perifosine and capecitabine
    Description
    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).
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johanna Bendell,, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    Citation
    Journal of Oncology, 2010 ASCO Annual Meeting Abstracts. Vol. 28, No. 15_suppl (May 20Supplement), 2010:e14086
    Results Reference
    result

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    Study of Perifosine + Capecitabine for Colon Cancer Patients

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