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A Phase 2 Study Of Perifosine In Metastatic Or Advanced Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

A Phase 2 Study Of Perifosine In Metastatic Or Advanced Breast Cancer


OBJECTIVES:

- Determine the objective tumor response rate in patients with recurrent or refractory,
locally advanced or metastatic breast cancer treated with perifosine.

- Determine the toxicity of this drug in these patients.

- Determine the stable disease rate, time to disease progression, objective response
duration, and duration of stable disease in patients treated with this drug.

- Correlate potential endpoints, including phosphorylated ERK, PKB, and SAPK,
phosphorylated PKC alpha, beta, and gamma isoforms, p21 ^WAF1; and activated capase-3
in tumor biopsies, with clinical outcome in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

Patients receive a loading dose of oral perifosine on days 1 and 2 and once daily on days
3-21 during course 1. Patients receive oral perifosine once daily on days 1-21 in each
subsequent course. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity. Patients achieving a complete response (CR) may receive 2 additional
courses beyond the CR.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 6-12
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed breast cancer

- Recurrent or refractory, locally advanced or metastatic disease

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR 10 mm by spiral CT scan

- Previously irradiated lesions are not considered measurable unless they have
demonstrated progression before study entry

- No measurable disease limited to bone lesions

- No known brain metastases

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex

- Male or female

Menopausal status

- Not specified

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

- No history of hemolytic disorder

Hepatic

- Bilirubin no greater than 1.25 times upper limit of normal (ULN)

- AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)

Renal

- Creatinine normal OR

- Creatinine clearance at least 60 mL/min

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No evidence of cardiac dysfunction

Gastrointestinal

- No history of biliary flow obstruction

- No abnormalities of the gastrointestinal tract that would preclude study drug
absorption

- No active peptic ulcer disease

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No ongoing or active infection

- No poorly controlled diabetes mellitus

- No other uncontrolled illness

- No prior allergic reactions to compounds of similar chemical or biological
composition to perifosine

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No more than 2 prior lines of chemotherapy for advanced disease, excluding adjuvant
chemotherapy

- Prior adjuvant chemotherapy allowed

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

Endocrine therapy

- At least 4 weeks since prior endocrine therapy

- Multiple lines of endocrine therapy for advanced disease allowed

Radiotherapy

- At least 4 weeks since prior radiotherapy and recovered

- Prior radiotherapy for metastatic disease allowed

Surgery

- No prior major gastric surgery

- Prior surgery, including for metastatic disease, allowed

Other

- No other concurrent anticancer or investigational agents

- No concurrent antiretroviral therapy in HIV-positive patients

- Concurrent bisphosphonates allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Natasha Leighl, MD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

United States: Federal Government

Study ID:

CDR0000269901

NCT ID:

NCT00054145

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • male breast cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms

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