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Perifosine in Treating Patients With Advanced Solid Tumors
This study has been completed.
Study NCT00005794   Information provided by National Cancer Institute (NCI)
First Received: June 2, 2000   Last Updated: July 23, 2008   History of Changes

June 2, 2000
July 23, 2008
February 2000
 
 
 
Complete list of historical versions of study NCT00005794 on ClinicalTrials.gov Archive Site
 
 
 
Perifosine in Treating Patients With Advanced Solid Tumors
A Phase I Trial of Perifosine on a Loading Dose/Maintenance Dose Schedule in Patients With Advanced Cancer

RATIONALE: Perifosine may stop the growth of tumor cells by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have advanced solid tumors.

OBJECTIVES:

  • Determine the maximum tolerated dose (MTD) of perifosine on a loading dose/maintenance dose schedule in patients with advanced solid tumors.
  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Investigate the relationship between pharmacokinetic parameters and toxicity of this drug in these patients.
  • Determine the recommended starting dose for phase II trials on this drug schedule in these patients.
  • Evaluate the pharmacodynamic parameters on peripheral blood lymphocytes both before and during drug administration in these patients.
  • Determine any changes in the MTD with prolonged administration (3 months, 6 months) of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive a loading dose of oral perifosine 4 times a day for 4-8 doses followed by a daily maintenance dose. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating loading doses and maintenance doses of perifosine until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxic effects.

PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: perifosine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed locally unresectable or metastatic malignancy that is considered incurable
  • Refractory to further treatment with known forms of effective therapy
  • No clinically active CNS metastasis

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • SGOT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after study participation
  • Maintaining a reasonable state of nutrition consistent with weight maintenance

    • No recent history of weight loss greater than 10% of current body weight
  • No frequent vomiting/poor alimentation
  • No other serious concurrent medical illness that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy

    • Patients who have progressive disease while being treated with LHRH agonists, antiestrogens, or antitestosterones for at least 3 months may remain on these agents if in their best interest

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 21 days since prior major surgery
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005794
 
CDR0000067752, WCCC-CO-99906, ASTA-D-21266, NCI-T99-0036
University of Wisconsin, Madison
National Cancer Institute (NCI)
Study Chair: Lynn Van Ummersen, MD University of Wisconsin, Madison
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP