NCT00054145

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

3.8 years

First QC Date

February 5, 2003

Last Update Submit

July 22, 2015

Conditions

Breast Cancer

Keywords

male breast cancerrecurrent breast cancerstage IV breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Interventions

perifosineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • Leighl NB, Dent S, Clemons M, Vandenberg TA, Tozer R, Warr DG, Crump RM, Hedley D, Pond GR, Dancey JE, Moore MJ. A Phase 2 study of perifosine in advanced or metastatic breast cancer. Breast Cancer Res Treat. 2008 Mar;108(1):87-92. doi: 10.1007/s10549-007-9584-x. Epub 2007 Apr 26.

    PMID: 17458693RESULT

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

perifosine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Natasha Leighl, MD, FRCPC

    Princess Margaret Hospital, Canada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

June 1, 2003

Primary Completion

April 1, 2007

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

CA(4)