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OpenTrials
Completed

NCT Number: NCT01048580

Study of Perifosine + Capecitabine for Colon Cancer Patients

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

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perifosine

Drug

Perifosine 50 mg orally once a day (Days 1-21)

Other names: D-21266, KRX-0401

Capecitabine

Drug

Capecitabine 1000 mg/m2 orally twice per day (Days 1-14)

Other names: Xeloda

Primary outcomes

  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 outcomes

  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:

    • Longest diameter ≥ 20 mm using conventional techniques, or
    • ≥ 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:

    • 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..

  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).

Sponsors and collaborators

Lead sponsor

AEterna Zentaris

Industry

Collaborators

  • SCRI Development Innovations, LLC

Registry information

Official study title

A Phase I Study of Perifosine + Capecitabine for Patients With Advanced Colon Cancer

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 13, 2010
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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