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Home > "T" Clinical Trials Conditions > Two Dose Levels of Capecitabine With Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer Who Have Not Responded to Previous Anthracycline-Based Chemotherapy

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



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

For Condition: stage 3C breast cancer,recurrent breast cancer,stage 3A breast cancer,stage 4 breast cancer,stage 3B breast cancer
Status: Recruiting
Sponsor(s): PharmaNet ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which dose of capecitabine is more effective when combined with docetaxel in treating breast cancer. PURPOSE: Randomizedphase II trial to compare the effectiveness of combining two dose levels of capecitabine with docetaxel in treating women who have locally advanced or metastatic breast cancer that has not responded to previous anthracycline-based chemotherapy (such as daunorubicin, doxorubicin, or epirubicin).
Details: OBJECTIVES: - 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. - Compare the toxicity of these 2 regimens in these patients. 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. PROJECTED ACCRUAL: A total of 440 patients (220 per treatment arm) will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AmanBuzdar,  Study Chair,  M.D. Anderson Cancer Center

North Shore Cancer Research Association *Recruiting*
Skokie,  Illinois,  60076
United States
Recruiting Marlon  Kleinman 847-675-3900

Baptist Regional Cancer Institute - Jacksonville *Recruiting*
Jacksonville,  Florida,  32207-8554
United States
Recruiting Neil  Abramson 904-202-7070

Hematology Oncology Associates of theTreasure Coast - Port St. Lucie *Recruiting*
Port Saint Lucie,  Florida,  34952
United States
Recruiting Nicholas  Iannotti 772-408-5159

Innovative Medical Research of South Florida, Incorporated *Recruiting*
Miami,  Florida,  33138
United States
Recruiting Marc  Saltzman 305-759-1881

Cancer Care Center *Recruiting*
Boston,  Massachusetts,  02118
United States
Recruiting Rita  Blanchard 617-414-1828

Baptist Regional Cancer Center - Knoxville *Recruiting*
Knoxville,  Tennessee,  37901
United States
Recruiting Tracy  Dobbs 865-549-4107

St. Mary Medical Center *Recruiting*
Walla Walla,  Washington,  99362
United States
Recruiting Matthew  Sacks 509-522-5993

Clinical Research Consultants, Incorporated *Recruiting*
Hoover,  Alabama,  35216
United States
Recruiting Luigi  Bertoli 205-824-3635 ext. 21

Maryland Hematology/Oncology Associates *Recruiting*
Baltimore,  Maryland,  21236
United States
Recruiting Myo  Thant 410-687-5300

Mercy Medical Center, Incorporated *Recruiting*
Baltimore,  Maryland,  21202-2165
United States
Recruiting David  Riseberg 410-332-9459

Regional Cancer Therapy Center - Frederick *Recruiting*
Frederick,  Maryland,  21701
United States
Recruiting Brian  O'Connor 301-662-8477

Saint Joseph Oncology, Incorporated *Recruiting*
St. Joseph,  Missouri,  64506
United States
Recruiting Robert  Weigand 816-271-1032

Liberty Hematology/Oncology *Recruiting*
Columbia,  South Carolina,  29203
United States
Recruiting M.  Gonzalez 803-779-6610

Southwest Regional Cancer Center *Recruiting*
Austin,  Texas,  78705
United States
Recruiting Robert  Kerr 512-421-4141

Cancer Outreach Associates - Abingdon *Recruiting*
Abingdon,  Virginia,  24211
United States
Recruiting Forrest  Swan 276-676-1870

Southwest Cancer Care *Recruiting*
Escondido,  California,  92025-4404
United States
Recruiting Michael  Kosmo 858-451-7066

Florida Wellcare Alliance, LLC *Recruiting*
Inverness,  Florida,  34452
United States
Recruiting Craig  Englund 352-341-2100

LeHigh Valley Women's Cancer Center *Recruiting*
Allentown,  Pennsylvania,  18104
United States
Recruiting Gazi  Abdulhay 610-366-8555

Carle Foundation Hospital - Carle Cancer Center *Recruiting*
Urbana,  Illinois,  61801
United States
Recruiting Kendrith  Rowland 217-383-6828

Indiana Oncology Hematology Consultants *Recruiting*
Indianapolis,  Indiana,  46202
United States
Recruiting Robert  Nelson 317-833-1215

Alta Bates Comprehensive Cancer Center *Recruiting*
Berkeley,  California,  94704
United States
Recruiting David  Irwin 510-204-3428

Associates in Oncology and Hematology *Recruiting*
Rockville,  Maryland,  20850
United States
Recruiting John  Wallmark 301-424-6231

Columbia Comprehensive Cancer Care Clinic *Recruiting*
Columbia,  Missouri,  65201
United States
Recruiting Ali  Khojasteh 573-893-6404

Genesis Cancer Center *Recruiting*
Hot Springs,  Arkansas,  71913
United States
Recruiting Tim  Webb 501-624-7700

Oncology & Hematology Associates of West Broward *Recruiting*
Tamarac,  Florida,  33321
United States
Recruiting Sumit  Sawhney 954-726-0035

Charleston Cancer Center *Recruiting*
Charleston,  South Carolina,  29406
United States
Recruiting Charles  Graham 843-576-1006

Center for Hematology-Oncology *Recruiting*
Boca Raton,  Florida,  33486
United States
Recruiting Howard  Adler 561-416-8869 ext. 247

Vermont Center for Cancer Medicine and Blood Disorders, Incorporated *Recruiting*
Colchester,  Vermont,  05446-3040
United States
Recruiting Christian  Thomas 802-655-7173 ext. 11

Summit Medical Group, P.A. *Recruiting*
Summit,  New Jersey,  07901
United States
Recruiting Michael  Wax 908-273-4300 ext. 5131

Arizona Clinical Research Center *Recruiting*
Tucson,  Arizona,  85712
United States
Recruiting Manuel  Modiano 520-290-2510

Medical Oncology Associates of Wyoming Valley, P.C. *Recruiting*
Kingston,  Pennsylvania,  18704-5527
United States
Recruiting Bruce  Saidman 570-262-3894

Medical Oncology and Hematology Associates *Recruiting*
Des Moines,  Iowa,  50309
United States
Recruiting Mark  Westberg 517-643-8757

Cancer Care Specialists *Recruiting*
Houma,  Louisiana,  70360
United States
Recruiting Raul  Doria 985-850-6329

Kansas City Cancer Centers - South *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Robert  Belt 913-541-4641

Family Cancer Center *Recruiting*
Collierville,  Tennessee,  38017
United States
Recruiting Donald  Gravenor 901-850-0272

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4009
United States
Recruiting Aman  Buzdar 713-792-2817


Additional Information:
Study ID Numbers:
  CDR0000367239;  PHARMANET-CRRI0403008,ROCHE-NO16853,PHARMANET-NO16853
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083200

Other Recurrent Breast Cancer Studies:
1. Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer

2. Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer

3. Combination Chemotherapy in Treating Patients With Stage III Breast Cancer

4. Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer

5. Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer

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

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