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A Phase II Trial Of Capecitabine In Combination With The Farnesyltransferase Inhibitor, R115777 (Tipifarnib and /or Zarnestra) In Patients With Metastatic Breast Cancer

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Trial Conditions
  • Breast Cancer
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Female

Eligibility

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

Gender: Female
Steward Physician(s)
  • William J. Gradishar, MD
  • Joseph A. Sparano, MD
  • Edith A. Perez, MD
Trial Interventions
Drug
  • capecitabine
  • tipifarnib
Physician Researcher

Investigator Name:

  • William J. Gradishar, MD
  • Joseph A. Sparano, MD
  • Edith A. Perez, MD

Other Information

Sponsor: Eastern Cooperative Oncology Group
Phase: Phase 2
Trial ID: NCT00077363
Volunteers:  Not Accepting Healthy Volunteers

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