Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: 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.

PURPOSE: This phase II trial is studying how well giving capecitabine together with tipifarnib works in treating women with taxane-resistant metastatic breast cancer.

Further Study Information

OBJECTIVES:

Primary

• Determine the response rate in women with taxane-resistant metastatic breast cancer treated with capecitabine and tipifarnib.

Secondary

• Determine the toxicity of this regimen in these patients.

• Determine the progression-free survival, time to treatment failure, and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

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.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 7 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

• Metastatic disease

• At least 1 objective measurable disease parameter

• No prior radiotherapy to only site of measurable disease

• Must have received prior anthracycline therapy (e.g., doxorubicin or epirubicin) in the adjuvant/neoadjuvant setting and/or for metastatic disease

• Must have received prior taxane therapy (e.g., paclitaxel or docetaxel) for metastatic disease OR relapsed while receiving adjuvant taxane therapy

• Progressive disease during or within 30 days after receiving prior taxane therapy

• No prior or concurrent brain metastases

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• Over 18

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count > 1,500/mm^3

• Platelet count > 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST and ALT ≤ 3 times ULN (5 times ULN if there is liver involvement by tumor)

Renal

• Creatinine ≤ 1.5 mg/dL OR

• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No symptomatic cardiovascular disease

Gastrointestinal

• No chronic nausea and vomiting

• No complete or partial bowel obstruction

• No dysphagia or odynophagia with inability to swallow pills

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No greater than grade 1 neuropathy

• No ongoing or active infection

• No other chronic medical or psychiatric illness that would preclude study participation or compliance

• No other concurrent uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• No prior capecitabine for metastatic disease

• No prior fluorouracil for metastatic disease

Endocrine therapy

• At least 1 week since prior hormonal therapy in the metastatic or adjuvant/neoadjuvant setting

Radiotherapy

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

• Prior radiotherapy to the conserved breast, to the postmastectomy chest wall, or to a limited field involving less than 25% of marrow-containing bone allowed

• No other prior radiotherapy

• No concurrent radiotherapy

Surgery

• No prior organ allograft

Other

• At least 4 weeks since prior cytotoxic drugs

• No prior tipifarnib

• No other prior farnesyl transferase inhibitors

• No prior immunosuppressive therapy

• No more than 3 prior cytotoxic regimens for metastatic disease

• No concurrent enzyme-inducing anticonvulsant medications (e.g., phenobarbital or phenytoin)

• No concurrent warfarin adjusted to an elevated INR

• Concurrent prophylactic low-dose warfarin (e.g., 1 mg daily) allowed provided PT and INR are normal

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

William John Gradishar

Study Chair

Joseph A. Sparano

Study Chair

Edith A. Perez

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00077363
Information obtained from ClinicalTrials.gov on December 14, 2011

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