Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer

NCT00077363 | Completed Phase 2

• 4 other identifiers: NCI-2012-02973E1103U10CA021115CDR0000350219
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well giving capecitabine together with tipifarnib works in treating women with taxane-resistant metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine, 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. Giving capecitabine together with tipifarnib may kill more tumor cells

Conditions

Recurrent Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (PR+CR)

  Up to 5 years

Secondary Outcomes (4)

• Progression-free survival (PFS)

  From registration to progression or to death from any cause without documentation of progression, assessed up to 5 years

• Time to treatment failure (TTF)

  From registration to disease progression, permanent discontinuation of treatment due to toxicity, or death, whichever occurs first, assessed up to 5 years

• Overall survival (OS)

  Up to 5 years

• Incidence of toxicities

  Up to 5 years

Study Arms (1)

Treatment (tipifarnib, capecitabine)

EXPERIMENTAL

Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 4 additional courses beyond documentation of CR.

Drug: tipifarnib; Drug: capecitabine

Interventions

tipifarnib DRUG

Given PO

Also known as: R115777, Zarnestra

Treatment (tipifarnib, capecitabine)

capecitabine DRUG

Given PO

Also known as: CAPE, Ro 09-1978/000, Xeloda

Treatment (tipifarnib, capecitabine)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with histologically confirmed adenocarcinoma of the breast with manifestations of metastatic progression
• Patients must have at least one objective measurable disease parameter as defined by RECIST criteria; tumor measurements and evaluation of non-measurable sites must be performed within 4 weeks prior to registration
• ECOG performance status 0-2
• Prior hormonal therapy in either the metastatic or adjuvant/neoadjuvant setting is allowed, but patients must have been off such therapy for greater than or equal to 1 week prior to registration
• No prior radiotherapy other than to the conserved breast, to the postmastectomy chest wall or to a limited field involving less than 25% of marrow - containing bone
• Previously irradiated tumors cannot be used to assess a clinical response; patients will not be eligible for this study if the previously irradiated tumors constitute the only site of measurable disease
• Patients must not have previously received tipifarnib or other farnesyl transferase inhibitors
• Patients must be disease-free of prior malignancies for \> 5 years with the exception of curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix
• Patients must have serum creatinine =\< 1.5 mg/dl or measured (or calculated) creatinine clearance \>= 60 mL/minute
• Granulocytes \> 1500/mm\^3
• Platelets \> 100,000/mm\^3
• Total bilirubin =\< 1.5 x upper limit of normal
• SGOT (AST) and SGPT (ALT) =\< 3 x upper limit of normal (unless liver is involved by tumor, in which case SGOT (AST) and SGPT (ALT) can be =\< 5 x upper limit of normal)
• Patients must not be pregnant or breastfeeding since there is no information regarding the use of these agents in this population; a negative serum or urine pregnancy test is required within 14 days prior to registration if pre- or perimenopausal (i.e., last menstrual period within one year of registration)
• Women of childbearing potential are strongly advised to use an accepted and effective method of contraception

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tipifarnib; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• William Gradishar

  Eastern Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 12, 2004
• Study Start: May 1, 2004
• Primary Completion: February 1, 2007
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

US (1)