NCT00049114|CompletedPhase 2

Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced Breast Cancer

A Phase I-II Study of R115777 (ZARNESTRA) Plus Doxorubicin and Cyclophosphamide in Patients With Locally Advanced Breast Cancer and Metastatic Breast Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

Compare

6 other identifiers

NCI-2012-0250002-05-125AECM-0205125NCI-5598CDR0000257811N01CM62204

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2003

StartedFeb 2003

Brief Summary

Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining tipifarnib with doxorubicin and cyclophosphamide may kill more tumor cells. Phase II trial to study the effectiveness of combining tipifarnib with doxorubicin and cyclophosphamide in treating women who have locally advanced breast cancer.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2

Geographic Reach

1 country

1 active site

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

November 12, 2002

Completed

3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

5 days until next milestone

Study Start

First participant enrolled

February 1, 2003

Completed

3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed

Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

3.9 years

First QC Date

November 12, 2002

Last Update Submit

June 5, 2013

Conditions

Inflammatory Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer

Outcome Measures

Primary Outcomes (1)

Pathological complete response in the breast
95% confidence intervals of these estimates will be obtained.
8 weeks

Secondary Outcomes (5)

Proportion of patients who have a clinical complete response
8 weeks
Grade 3 or 4 toxicities assessed using NCI CTCAE version 3.0
Up to 5 years
Median disease-free survival
Up to 5 years
Percentage of patients free of disease
1 year
Percentage of patients free of disease
2 years

Study Arms (1)

Treatment (doxorubicin, cyclophosphamide, tipifarnib, G-CSF)

EXPERIMENTAL

PHASE I (nonregional stage IV disease) (closed to accrual as of 1/19/04): Patients receive doxorubicin IV over 10-15 minutes and cyclophosphamide IV over 30 minutes on day 1, oral tipifarnib twice daily on days 2-7, and G-CSF subcutaneously on days 2-13. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. PHASE II (stage IIB, IIIA, IIIB, or IIIC): Patients receive tipifarnib at the MTD and doxorubicin, cyclophosphamide, and G-CSF as in phase I (phase I closed to accrual as of 1/19/04). After the fourth course, patients may undergo complete resection.

Drug: doxorubicin hydrochlorideDrug: cyclophosphamideDrug: tipifarnibBiological: filgrastimProcedure: therapeutic conventional surgeryOther: laboratory biomarker analysis