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Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: February 10, 2004   Last Updated: July 23, 2008   History of Changes
Sponsor: Eastern Cooperative Oncology Group
Collaborators: 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

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

Resource links provided by NLM:


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

  Hide Study Locations
Locations
United States, California
Comprehensive Cancer Center at Community Hospital of the Monterey Peninsula
Monterey, California, United States, 93940
Memorial Medical Center Cancer Services
Modesto, California, United States, 95355
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224-2522
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
North Suburban Medical Center
Thorton, Colorado, United States, 80229
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80502
Rose Medical Center
Denver, Colorado, United States, 80220
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
St. Joseph Hospital
Denver, Colorado, United States, 80218
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
Swedish Medical Center
Englewood, Colorado, United States, 80110
United States, Florida
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States, 33805
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Georgia
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
Winship Cancer Institute of Emory University
Altanta, Georgia, United States, 30322
United States, Illinois
Alexian Brothers Radiation Oncology
Elk Grove Village, Illinois, United States, 60007
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States, 60126
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Graham Hospital
Canton, Illinois, United States, 61520
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States, 60076
Hematology/Oncology of the North Shore at Gross Point Medical Center
Skokie, Illinois, United States, 60076
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Memorial Hospital
Carthage, Illinois, United States, 62321
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Midwest Cancer Research Group, Incorporated
Skokie, Illinois, United States, 60077
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States, 60432
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, United States, 60048
Northwest Medical Specialist, PC
Niles, Illinois, United States, 60714
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Proctor Hospital
Peoria, Illinois, United States, 61614
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
Olympia Fields, Illinois, United States, 60461
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Swedish Covenant Hospital
Chicago, Illinois, United States, 60625
Trinity Medical Center - East
Moline, Illinois, United States, 61265
United States, Indiana
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
United States, Iowa
Burgess Health Center
Onawa, Iowa, United States, 51040
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
McFarland Clinic, P. C.
Ames, Iowa, United States, 50010
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States, 50266
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Ottumwa Regional Health Center Cancer Center
Ottumwa, Iowa, United States, 52501
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
Sioux City, Iowa, United States, 51101
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
St. Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Associates in Womens Health, P.A. - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, P.A. - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, P.A. - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, P.A. - Winfield
Winfield, Kansas, United States, 67156
Cancer Center of Kansas, P.A. - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, P.A. - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, P.A. - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, P.A. - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, P.A. - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
CCOP - Wichita
Wichita, Kansas, United States, 67214
Southwest Medical Center
Liberal, Kansas, United States, 67901
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Louisiana
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, United States, 70806
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Commonwealth Hematology-Oncology P. C. - Quincy
Quincy, Massachusetts, United States, 02169
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Borgess Medical Center
Kalamazooaa, Michigan, United States, 49001
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Foote Hospital
Jackson, Michigan, United States, 49201
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Haematology-Oncology Associates of Ohio and Michigan, P.C.
Lambertville, Michigan, United States, 48144
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Hurley Medical Center
Flint, Michigan, United States, 48503
Mercy Memorial Hospital System
Monroe, Michigan, United States, 48162
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States, 48601
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
St. John Macomb Hospital
Warren, Michigan, United States, 48093
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
United States, Minnesota
United Hospital
St. Paul, Minnesota, United States, 55102
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
MeritCare Clinic - Bemidji
Bemidji, Minnesota, United States, 56601
Miller-Dwan Medical Center
Duluth, Minnesota, United States, 55805
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Montana
Benefis Healthcare's Sletten Regional Cancer Institute
Great Falls, Montana, United States, 59405
Big Sky Oncology
Great Falls, Montana, United States, 59405
United States, Nebraska
Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States, 68046-4194
United States, New Jersey
Booker Cancer Center at Riverview Medical Center
Red Bank, New Jersey, United States, 07701
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Mountainside Hospital Cancer Center
Montclair, New Jersey, United States, 07042
Fox Chase Virtua Health Cancer Program - Marlton
Marlton, New Jersey, United States, 08053
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
Somerset Medical Center
Somerville, New Jersey, United States, 08876
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx, New York, United States, 10466
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
MeritCare Medical Group
Fargo, North Dakota, United States, 58122
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, P. C.
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center
Bismarck, North Dakota, United States, 58502
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44309-2090
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623
CCOP - Dayton
Dayton, Ohio, United States, 45429
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Fremont Memorial Hospital
Fremont, Ohio, United States, 43420
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grandview Hospital
Dayton, Ohio, United States, 45405
Kenton Oncology, Incorporated
Kenton, Ohio, United States, 43326
Promedica Cancer Center at Flower Hospital
Sylvania, Ohio, United States, 43560
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, United States, 44708
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
St. Luke's Hospital
Maumee, Ohio, United States, 43537
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Hospital
Toledo, Ohio, United States, 43606
Toledo Surgical Specialists
Toledo, Ohio, United States, 43623
United States Air Force Medical Center Wright-Patterson
Wright-Patterson Afb, Ohio, United States, 45433-5529
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Central Pennsylvania Hematology and Medical Oncology Associates, P. C.
Lemoyne, Pennsylvania, United States, 17043
Easton Regional Cancer Center at Easton Hospital
Easton, Pennsylvania, United States, 18042
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Hematology and Oncology Associates
Scranton, Pennsylvania, United States, 18510
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
Erlanger Cancer Center
Chattanooga, Tennessee, United States, 37403
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Wisconsin
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States, 54501
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
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

Additional Information:
Publications:
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     History of Changes
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 30, 2009