Know Cancer

or
forgot password

A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer


OBJECTIVES:

- Determine the 4-month progression-free survival rate, as measured by prostate-specific
antigen and clinical criteria, in patients with metastatic androgen-independent
prostate cancer treated with perifosine.

- Determine the side-effect profile of this drug in these patients.

- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

OUTLINE:

- Course 1: Patients receive oral perifosine twice on day 1 and once daily on days 2-21.

- All subsequent courses: Patients receive oral perifosine once daily on days 1-21.

In all courses, treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.

PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within
approximately 1.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate, meeting all of the following
criteria:

- Metastatic

- Androgen-independent

- Progressive disease while continuing to receive hormonal ablation (e.g.,
luteinizing hormone-releasing hormone [LHRH] agonist)

- Progression documented by at least 1 of the following parameters:

- Two consecutively rising prostate-specific antigen levels, at least 1 week
apart, with at least 1 measurement that is 50% above the nadir reached after the
last treatment regimen (as long as the last measurement is at least 5 ng/mL)

- At least 1 new metastatic lesion on technetium Tc 99m bone scintigraphy

- Progression of soft-tissue metastases as measured by appropriate modalities
(i.e., imaging or palpation) and demonstrated by at least 1 of the following:

- Development of new area of malignant disease (measurable or nonmeasurable)

- At least a 20% increase in the sum of the longest diameters (LD) of target
lesions from the smallest sum of LD recorded since the treatment started or
the appearance of 1 or more new lesions

- Patients who have not undergone surgical castration must have a testosterone level
less than 50 ng/mL and continue on their LHRH agonist during study treatment

- No known brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- More than 3 months

Hematopoietic

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin less than 1.0 mg/dL or upper limit of normal (ULN)

- AST/ALT no greater than 2.5 times ULN

Renal

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular

- No myocardial infarction within the past 6 months

- No unstable or newly diagnosed angina pectoris

- No New York Heart Association class II-IV congestive heart failure

Ophthalmic

- No pre-existing retinal disease

- No pathologic baseline electrooculogram

Other

- Fertile patients must use effective barrier contraception

- Able to ingest oral medication

- No prior allergic reactions attributed to compounds of similar chemical or biological
composition to perifosine (e.g., miltefosine or edelfosine)

- No ongoing or active infection

- No other concurrent uncontrolled illness

- No psychiatric illness or social situation that would preclude study compliance

- No other active malignancies within the past 2 years except nonmelanoma skin cancer
or carcinoma in situ of the bladder

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No more than 1 prior chemotherapy regimen

- More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or
mitomycin)

Endocrine therapy

- See Disease Characteristics

- More than 4 weeks since prior flutamide

- More than 6 weeks since prior bicalutamide or nilutamide

Radiotherapy

- At least 6 weeks since prior bone-seeking radioisotopes

- Recovered from prior radiotherapy

Surgery

- See Disease Characteristics

- Recovered from prior surgery

Other

- Recovered from any acute toxicity related to prior therapy

- More than 3 months since prior UCN-01

- More than 3 months since prior suramin

- No concurrent commercial or other investigational agents or therapies intended to
treat the malignancy

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Edwin M. Posadas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000301951

NCT ID:

NCT00060437

Start Date:

October 2003

Completion Date:

April 2004

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182