Perifosine in Treating Patients With Recurrent, Refractory, Locally Advanced, or Metastatic Breast Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: perifosine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study Of Perifosine In Metastatic Or Advanced Breast Cancer |
| Study Start Date: | June 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Ontario | |
| Margaret and Charles Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Cancer Care Ontario-London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Study Chair: | Natasha Leighl, MD, FRCPC | Princess Margaret Hospital, Canada |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00054145 History of Changes |
| Other Study ID Numbers: | CDR0000269901, PMH-PHL-014, NCI-5982 |
| Study First Received: | February 5, 2003 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
male breast cancer recurrent breast cancer stage IV breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013