Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Two Dose Levels of Capecitabine With Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Anthracycline-Based Chemotherapy

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over Pharmaceutical / Industry PHARMANET-NO16853 PHARMANET-CRRI0403008, ROCHE-NO16853, NCT00083200

Objectives

1. Compare the clinical efficacy of 2 dose levels of capecitabine when given in combination with docetaxel in women with locally advanced or metastatic breast cancer previously treated with anthracycline-based chemotherapy.
2. Compare the toxicity of these 2 regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed breast cancer
  • Locally advanced or metastatic disease



• Failed prior anthracycline-based chemotherapy



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy

Endocrine therapy

• More than 10 days since prior hormonal therapy

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Not specified

Patient Characteristics:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Karnofsky 70-100%

Life expectancy

• More than 3 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Creatinine clearance ≥ 30 mL/min

Other

• Able to swallow study medication
• Must have good upper gastrointestinal tract integrity
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 440 patients (220 per treatment arm) will be accrued for this study.

Outcomes

Clinical efficacy
Toxicity

Outline

This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive standard-dose oral capecitabine twice daily on days 1-14 and docetaxel IV on day 1.



• Arm II: Patients receive lower-dose oral capecitabine twice daily on days 1-14 and docetaxel as in arm I.

In both arms, treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

Trial Contact Information

Trial Lead Organizations

PharmaNet - Blue Bell

Aman Buzdar, MD, Protocol chair		Ph: 713-792-2817; 800-392-1611

U.S.A.
Alabama
	Hoover
	Clinical Research Consultants, Incorporated
		Luigi Bertoli, MD	Ph:  205-824-3635 ext. 21
			Email: rkilgore@bellsouth.net
Arizona
	Tucson
	Arizona Clinical Research Center, Incorporated
		Manuel Modiano, MD	Ph:  520-290-2510
California
	Berkeley
	Alta Bates Summit Comprehensive Cancer Center
		David Irwin, MD	Ph:  510-204-3428
			Email: dirwin@aptiumoncology.com
	Escondido
	Southwest Cancer Care - Escondido
		Michael Kosmo, MD	Ph:  858-451-7066
			Email: makosmo@swcancer.com
Florida
	Boca Raton
	Center for Hematology-Oncology - Boca Raton
		Howard Adler, MD	Ph:  561-416-8869 ext. 247
	Inverness
	Florida Wellcare Alliance, LLC
		Craig Englund, MD	Ph:  352-341-2100
	Jacksonville
	Baptist Cancer Institute - Jacksonville
		Neil Abramson, MD	Ph:  904-202-7070
			Email: abrm1h@bellsouth.net
	North Miami Beach
	Innovative Medical Research of South Florida, Incorporated
		Marc Saltzman, MD	Ph:  305-759-1881
			Email: innmed1@aol.com
	Port Saint Lucie
	Hematology Oncology Associates of the Treasure Coast - Port St. Lucie
		Nicholas Iannotti, MD	Ph:  772-408-5159
	Tamarac
	Oncology & Hematology Associates of West Broward
		Sumit Sawhney, MD	Ph:  954-726-0035
Illinois
	Skokie
	North Shore Cancer Research Association
		Marlon Kleinman, MD	Ph:  847-675-3900
			Email: marlonbk@comcast.net
	Urbana
	Carle Cancer Center at Carle Foundation Hospital
		Kendrith Rowland, MD	Ph:  217-383-6828
			Email: kendrith.rowland@carle.com
Indiana
	Indianapolis
	American Health Network - North Meridian
		Clinical Trial Office - American Health Network	Ph:  317-782-7820
Iowa
	Des Moines
	Medical Oncology and Hematology Associates at John Stoddard Cancer Center
		Mark Westberg, MD	Ph:  517-643-8757
Louisiana
	Houma
	Cancer Care Specialists
		Raul Doria, MD	Ph:  985-850-6329
Maryland
	Baltimore
	Maryland Hematology/Oncology Associates
		Myo Thant, MD	Ph:  410-687-5300
	Mercy Medical Center
		David Riseberg, MD	Ph:  410-332-9459
			Email: driseberg@mdmercy.com
	Frederick
	Frederick Memorial Hospital Regional Cancer Therapy Center
		Brian O'Connor, MD	Ph:  301-662-8477
			Email: boconnor@fmh.org
	Rockville
	Associates in Oncology and Hematology - Medical Center Drive
		John Wallmark, MD	Ph:  301-424-6231
			Email: jwall@aohmd.com
Massachusetts
	Boston
	Cancer Care Center of BMC - Boston
		Rita Blanchard, MD	Ph:  617-414-1828
			Email: rita.blanchard@bmc.org
Missouri
	Columbia
	Columbia Comprehensive Cancer Care Clinic
		Clinical Trials Office - Columbia Comprehensive Cancer Care Clinic	Ph:  573-893-6404
	Kansas City
	Kansas City Cancer Centers - South
		Robert Belt, MD	Ph:  913-541-4637
	Saint Joseph
	Saint Joseph Oncology, Incorporated
		Robert Weigand, MD	Ph:  816-271-1301
New Jersey
	Summit
	Summit Medical Group, PA - Summit
		Michael Wax, MD	Ph:  908-273-4300 ext. 5131
			Email: mwax@smgnj.com
Pennsylvania
	Allentown
	Lehigh Valley Women's Cancer Center
		Gazi Abdulhay, MD, FACOG, FACS	Ph:  610-366-8555
			Email: gabdulhay@lvwcc.com
	Kingston
	Medical Oncology Associates of Wyoming Valley, PC
		Bruce Saidman, MD	Ph:  570-262-3894
			Email: bsaidman@moawv.com
South Carolina
	Charleston
	Charleston Cancer Center
		Charles Graham, MD	Ph:  843-576-1006
	Columbia
	Medical Oncology-Hematology
		M. Francisco Gonzalez, MD, PA	Ph:  803-779-6610
			Email: meg1176@aol.com
Tennessee
	Collierville
	Family Cancer Center, PLLC - Collierville
		Donald Gravenor, MD	Ph:  901-850-0272 888-685-8346
	Knoxville
	Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
		Tracy Dobbs, MD	Ph:  865-549-4107
Texas
	Austin
	Southwest Regional Cancer Center - Central
		Robert Kerr, MD	Ph:  512-421-4141
			Email: RKerr@swrcc.com
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
Vermont
	Colchester
	Vermont Center for Cancer Medicine and Blood Disorders, Incorporated
		Christian Thomas, MD	Ph:  802-655-7173 ext. 11
			Email: christian.thomas@vtmednet.org
Virginia
	Abingdon
	Cancer Outreach Associates - Abingdon
		Forrest Swan, MD	Ph:  276-676-1870
Washington
	Walla Walla
	St. Mary Regional Cancer Center at St. Mary Medical Center
		Matthew Sacks, MD	Ph:  509-522-5993
			Email: adameh@smmc.com

Registry Information
Official Title		Open-Label Randomized Study of Two Different Dosing Regimens of Capecitabine in Combination with Intravenous Docetaxel (Q3W) in Patients with Metastatic Breast Cancer Whose Disease has Progressed After Failure of Prior Anthracycline Containing Chemotherapy
Trial Start Date		2003-07-31
Registered in ClinicalTrials.gov		NCT00083200
Date Submitted to PDQ		2004-04-15
Information Last Verified		2008-08-08

Back to Top