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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 Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about 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 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like 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 Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a 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 clinical trial. Subjects frequently get the best healthcare possible for their 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 condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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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
Related Studies:
Other recurrent breast cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Allentown Clinical Trials
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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