A Phase I Trial of Perifosine on a Loading Dose/Maintenance Dose Schedule in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Trial of Perifosine on a Loading Dose/Maintenance Dose Schedule in Patients With Advanced Cancer


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Lynn Van Ummersen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Federal Government

Study ID:

CDR0000067752

NCT ID:

NCT00005794

Start Date:

February 2000

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792