NCT00100750

Brief Summary

This phase I/II trial is studying the side effects and best dose of tipifarnib when given together with gemcitabine hydrochloride and to see how well they work in treating women with breast cancer that has spread to other parts of the body. Tipifarnib is a drug that binds to specific proteins on the tumor cells and then kills these cells. Gemcitabine hydrochloride is a chemotherapy drug that may kill tumor cells by preventing cells from dividing. Giving tipifarnib together with gemcitabine hydrochloride may kill more tumor cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2005

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 13, 2015

Status Verified

October 1, 2014

Enrollment Period

2.1 years

First QC Date

January 6, 2005

Last Update Submit

January 12, 2015

Conditions

Recurrent Breast CarcinomaStage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR) using the Response Evaluation Criteria in Solid Tumors (RECIST)

    Up to 9 years

Secondary Outcomes (3)

  • Time to disease progression using RECIST

    Up to 9 years

  • Incidence of adverse events observed during treatment, graded using the Common Terminology Criteria for Adverse Events version 4.0

    Up to 30 days after completion of study treatment

  • ORR, by type and extent of prior chemotherapy

    Up to 9 years

Other Outcomes (1)

  • Change in serum proteomic analysis

    Baseline to up to 9 years

Study Arms (1)

Treatment (gemcitabine hydrochloride, tipifarnib)

EXPERIMENTAL

Patients receive tipifarnib PO BID on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Gemcitabine HydrochlorideDrug: TipifarnibOther: Laboratory Biomarker Analysis

Interventions

Gemcitabine HydrochlorideDRUG

Given IV

Also known as: dFdC, dFdCyd
Treatment (gemcitabine hydrochloride, tipifarnib)
TipifarnibDRUG

Given PO

Also known as: R115777, Zarnestra
Treatment (gemcitabine hydrochloride, tipifarnib)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (gemcitabine hydrochloride, tipifarnib)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed breast cancer and clinical evidence of metastatic disease
  • Patients may have received any number or type of hormonal therapies, either for stage IV disease and/or as adjuvant therapy; patients may have received trastuzumab therapy
  • Patients may have received up to 2 prior chemotherapy regimens as therapy for metastatic breast cancer; patients must have recovered from the myelosuppressive effects of prior chemotherapy and all toxicity must have recovered to grade less than or equal to 1
  • Concomitant bisphosphonates are allowed for patients with bone metastases
  • Localized radiotherapy that does not influence the single evaluable lesion is allowed prior to the initiation of therapy; patients must have recovered from the myelosuppressive effects of previous radiotherapy (at least 4 weeks)
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm with spiral computed tomography (CT) scan
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky \> 60%)
  • Leukocytes \>= 3,000/mcL
  • Absolute neutrophil count \>= 1,500/mcL
  • Platelets \>= 100,000/mcL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 Ă— institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document
  • +1 more criteria

You may not qualify if:

  • Prior therapy with farnesyltransferase inhibitor or gemcitabine for metastatic breast cancer
  • Patients with leptomeningeal disease and/or brain metastasis
  • Patients with symptomatic lymphangitic pulmonary metastases
  • Patients with peripheral neuropathy greater than or equal to grade 2
  • No history of concomitant malignancy except for non-melanoma skin cancer or cervical cancer in situ or other malignancy treated curatively and no evidence of disease for at least five years
  • Patients who have had chemotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients may not be receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to tipifarnib (R115777), or imidazole derivatives
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabinetipifarnib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Banu Arun

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2005

First Posted

January 7, 2005

Study Start

September 1, 2005

Primary Completion

October 1, 2007

Study Completion

January 1, 2010

Last Updated

January 13, 2015

Record last verified: 2014-10

Locations

US(1)