Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 435 for:    colon cancer AND Capecitabine
Previous Study | Return to List | Next Study

Study of Perifosine + Capecitabine for Colon Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01048580
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : June 28, 2018
Sponsor:
Collaborator:
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
AEterna Zentaris

Brief Summary:
This is a Phase I study of Perifosine + Capecitabine for patients with advanced colon cancer.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: Perifosine Drug: Capecitabine Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Perifosine + Capecitabine for Patients With Advanced Colon Cancer
Study Start Date : October 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


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).
Drug: Perifosine
Perifosine 50 mg orally once a day (Days 1-21)
Other Names:
  • D-21266
  • KRX-0401

Drug: Capecitabine
Capecitabine 1000 mg/m2 orally twice per day (Days 1-14)
Other Name: Xeloda




Primary Outcome Measures :
  1. 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):

    • 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 :
  1. 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:

    1. Longest diameter ≥ 20 mm using conventional techniques, or
    2. ≥ 10 mm with spiral CT scan.

  2. 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:

    1. The site of disease must have been evaluated either at baseline or while receiving study medication. Both evaluations must use the same methodology.
    2. PET scan results will not be used as evidence of either progression or response..

  3. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048580


Sponsors and Collaborators
AEterna Zentaris
SCRI Development Innovations, LLC
Investigators
Layout table for investigator information
Study Chair: Johanna Bendell,, MD SCRI Development Innovations, LLC

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

Layout table for additonal information
Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT01048580     History of Changes
Other Study ID Numbers: Perifosine 141
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: November 2011
Keywords provided by AEterna Zentaris:
Perifosine
Capecitabine
Colon Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents