A Phase 1/2 Trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT00399789
First received: November 13, 2006
Last updated: February 11, 2014
Last verified: February 2012
  Purpose

This is a study of the drug perifosine that consists of 2 parts. The first part of this study was designed to determine the highest dose of perifosine that can be administered to people every week without severe or prolonged nausea, vomiting and diarrhea. This study started with patients taking 900 mg/week and went up to 1800 mg/week. Part I of this study is completed. The MTD had been determined and incorporated in Part II.

The goals in Part II are to:

  1. Compare the gastrointestinal toxicity of 3 different dose-schedules and
  2. Obtain preliminary information on the response rate of perifosine in non-small cell lung cancer.

Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Perifosine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2 Trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:
  • Gastrointestinal toxicity of 3 different dose-schedules [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Preliminary information on response rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: September 2004
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Perifosine 150 mg qd Drug: Perifosine
Perifosine will be tested in 3 dose forms
Other Name: perifosine
Active Comparator: Perifosine 900 mg per week Drug: Perifosine
Perifosine will be tested in 3 dose forms
Other Name: perifosine
Active Comparator: Perifosine 50 mg tid Drug: Perifosine
Perifosine will be tested in 3 dose forms
Other Name: perifosine

Detailed Description:

The primary purpose of Part I of this study was to determine the maximum dose of perifosine that can be administered with tolerable gastrointestinal toxicity; and to obtain preliminary information on the response rate of perifosine in non-small cell lung cancer. In addition, the trial was and is designed to provide some insight into the nature of the anti-tumor effect, the time to response, and dose-schedules that should be used in future trials.

Part 2 - In the second part of this study, patients will be randomized to one of 3 dose-schedules of perifosine and to test if the response rate of perifosine in non small cell lung cancer is > 10% in any of the 3 arms of the study. The study is not designed to compare the response rates in the 3 arms of the trial, but toxicities will be compared. The regimens are:

  • A weekly dose of 900 mg to be divided into three doses of 300 mg each. If patients experience no grade 2 toxicities during their first month of therapy, the dose will be escalated to 1,200 mg divided into four doses of 300 mg.
  • A daily dose of 150 mg to be divided into three doses of 50 mg each. If patients experience no grade 2 toxicities during their first month of therapy, the dose will be escalated to 200 mg divided into four doses of 50 mg.
  • A daily dose of 150 mg to be given in one dose at bedtime. If patients experience no grade 2 toxicities during their first month of therapy, the dose will be escalated to 200 mg to be given in one dose at bedtime.

Patients receiving weekly perifosine will receive prophylactic antiemetics. Patients receiving daily perifosine will not routinely receive prophylactic antiemetics unless they experience nausea. All patients may continue therapy unless disease progression is documented on two occasions at least 4 weeks apart. Patients who experience toxicity may continue on treatment with doses delayed or reduced.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed diagnosis of non-small cell lung cancer, must have progressed despite standard therapy and must not be candidates for surgical or combined modality therapy.
  • At least 18 years of age.
  • Patients should have received at least one but no more than two prior chemotherapy regimens for metastatic disease. The study chairman or medical monitor will consider extenuating circumstances for patients with more than two such regimens.
  • Patients must have measurable disease. Since the outcome for a patient is to be based on response using RECIST criteria, the patient must have at least one measurable lesion 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.
  • Patients must have a life expectancy of more than 3 months.
  • Patients should have a performance status of 0 to 1 according to the ECOG criteria. However, patients with ECOG performance status of 2 may be admitted with approval from the study chairman or medical monitor.
  • Female patients who are pregnant or lactating are ineligible. All females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment. Men and women of childbearing potential must agree to employ adequate contraception to prevent pregnancy while on therapy and for four weeks after the completion of treatment.
  • Patients must have ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

  • Patients with rapidly progressing disease, as defined by progression within 12 weeks of initiation of the previous regimen.
  • 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 and psychiatric illness/social situations that would limit compliance with study requirements.
  • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399789

Locations
United States, Arizona
AOI Pharmaceuticals Investigative Site
Tucson, Arizona, United States, 85704
United States, California
AOI Pharmaceuticals Investigative Site
Pomona, California, United States, 91767
United States, Florida
AOI Pharmaceuticals Investigative Site
Aventura, Florida, United States, 33180
AOI Pharmaceuticals Investigative Site
Hollywood, Florida, United States, 33021
AOI Pharmaceuticals Investigative Site
Lakeland, Florida, United States, 33805
AOI Pharmaceuticals Investigative Site
Ormond Beach, Florida, United States, 32174
United States, Georgia
AOI Pharmaceuticals Investigative Site
Lawrenceville, Georgia, United States, 30045
United States, Illinois
AOI Pharmaceuticals Investigative Site
Galesburg, Illinois, United States, 61401
United States, Indiana
AOI Pharmaceuticals Investigative Site
New Albany, Indiana, United States, 47150
United States, Michigan
AOI Pharmaceuticals Investigative Site
Grand Rapids, Michigan, United States, 49546
AOI Pharmaceuticals Investigative Site
Kalamazoo, Michigan, United States, 49048
United States, Montana
AOI Pharmaceuticals Investigative Site
Billings, Montana, United States, 59101
United States, New Mexico
AOI Pharmaceuticals Investigative Site
Albuquerque, New Mexico, United States, 87109
United States, New York
AOI Pharmaceuticals Investigative Site
Albany, New York, United States, 12208
AOI Pharmaceuticals Investigative Site
Armonk, New York, United States, 10504
United States, South Carolina
AOI Pharmaceuticals Investigative Site
Greenville, South Carolina, United States, 29605
United States, Tennessee
AOI Pharmaceuticals Investigative Site
Chattanooga, Tennessee, United States, 37404
AOI Pharmaceuticals Investigative Site
Nashville, Tennessee, United States, 37203
United States, Texas
AOI Pharmaceuticals Investigative Site
Dallas, Texas, United States, 75237
AOI Pharmaceuticals Investigative Site
Dallas, Texas, United States, 75246
AOI Pharmaceuticals Investigative Site
Tyler, Texas, United States, 75702
Sponsors and Collaborators
AEterna Zentaris
Investigators
Principal Investigator: David Spigel, MD SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT00399789     History of Changes
Other Study ID Numbers: Perifosine 201
Study First Received: November 13, 2006
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AEterna Zentaris:
Non-Small-Cell Lung
Perifosine

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014