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Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00077363
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: capecitabine
Drug: tipifarnib
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Capecitabine Tipifarnib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial Of Capecitabine In Combination With The Farnesyltransferase Inhibitor, R115777 (Tipifarnib and /or Zarnestra) In Patients With Metastatic Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate (partial and complete response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Study Start Date: May 2004
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077363

  Show 226 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Investigators
Study Chair: William J. Gradishar, MD Robert H. Lurie Cancer Center
Investigator: Joseph A. Sparano, MD Albert Einstein College of Medicine of Yeshiva University
Study Chair: Edith A. Perez, MD Mayo Clinic
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Wang M, Gradishar WJ, Sparano JA, et al.: A phase II trial of capecitabine (C) in combination with the farnesyltransferase (FT) inhibitor (FTI), tipifarnib (T), in patients (pt) with metastatic breast cancer (MBC): ECOG trial 1103. [Abstract] J Clin Oncol 25 (Suppl 18): A-1036, 2007.

Study ID Numbers: CDR0000350219, ECOG-E1103, NCCTG-E1103
Study First Received: February 10, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00077363  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Study placed in the following topic categories:
Capecitabine
Skin Diseases
Breast Neoplasms
Taxane
Breast Diseases
Recurrence
Tipifarnib

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009