NCT00052728

Brief Summary

RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Tamoxifen may fight breast cancer by blocking the use of estrogen. Combining tipifarnib with tamoxifen may be effective treatment for metastatic breast cancer. PURPOSE: This phase II trial is studying how well giving tipifarnib together with tamoxifen works in treating women with metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

December 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

June 19, 2013

Status Verified

May 1, 2005

First QC Date

January 24, 2003

Last Update Submit

June 18, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

tamoxifen citrateDRUG
tipifarnibDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of metastatic (stage IV) breast cancer * Evidence of disease progression * Measurable disease * Must have been previously treated with at least 1 hormonal therapy with either an aromatase inhibitor or an estrogen receptor (ER)-modulating drug in the adjuvant or metastatic setting and meets 1 of the following criteria: * Hormone-responsive disease: * Stable disease (no recurrence or progression for at least 6 months) * Objective response * Hormone-nonresponsive disease: * No stable disease * No objective response * Previously treated CNS disease allowed provided patient has a life expectancy of at least 3 months (phase I patients) (Phase I closed to accrual effective 10/23/2003) * No CNS metastases (phase II patients) * Hormone receptor status: * ER and/or progesterone receptor positive * NOTE: As few as 1% positive cells considered positive PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * Zubrod 0-1 Life expectancy * See Disease Characteristics Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 2.0 mg/dL (unless evidence of Gilbert's disease) * SGOT and SGPT less than 3 times upper limit of normal (unless liver involvement by tumor) Renal * Creatinine no greater than 1.5 mg/dL Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective nonhormonal contraception during and for 2 months after study participation * No medical or psychiatric condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No more than 2 prior chemotherapy regimens for metastatic disease (phase II patients) * No limitations on prior neoadjuvant or adjuvant regimens * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy * See Disease Characteristics * At least 6 months since prior tamoxifen * Concurrent stable dose of steroids allowed (phase I patients) (Phase I closed to accrual effective 10/23/2003) Radiotherapy * No concurrent radiotherapy Surgery * Concurrent surgery allowed provided the need for surgery is not due to disease progression Other * Recovered from all prior therapy * No prior warfarin * No concurrent cytochrome p450-inducing anti-convulsants * No other concurrent anticancer therapies * Concurrent bisphosphonates for bone metastases allowed

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

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • Lebowitz PF, Eng-Wong J, Widemann BC, Balis FM, Jayaprakash N, Chow C, Clark G, Gantz SB, Venzon D, Zujewski J. A phase I trial and pharmacokinetic study of tipifarnib, a farnesyltransferase inhibitor, and tamoxifen in metastatic breast cancer. Clin Cancer Res. 2005 Feb 1;11(3):1247-52.

    PMID: 15709195RESULT

  • Lebowitz PF, Eng-Wong J, Balis F, et al.: A phase I trial of tipifarnib, a farnesyltransferase inhibitor, and tamoxifen in hormone-receptor positive metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22 (Suppl 14): A-644, 38s, 2004.

    RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifentipifarnib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • JoAnne Zujewski, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

December 1, 2002

Study Completion

July 1, 2006

Last Updated

June 19, 2013

Record last verified: 2005-05

Locations

US(2)