Perifosine in Treating Patients With Recurrent, Refractory, Locally Advanced, or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have recurrent, refractory, locally advanced, or metastatic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: National Cancer Institute (NCI)

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