- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00026442
Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer
A Pilot Trial Of Two Different Doses Of Capecitabine (XELODA) In Patients With Advanced And/Or Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of capecitabine in treating women who have advanced or metastatic breast cancer.
Study Overview
Detailed Description
OBJECTIVES:
- Compare the objective response rate in women with advanced or metastatic breast cancer treated with two dose levels of capecitabine.
- Compare the duration of response, time to progression, time to treatment failure, survival, incidence of adverse events, and time to onset of the adverse experience in patients treated with this drug.
- Compare the quality of life of patients treated with this drug.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Karnofsky performance status (70-80% vs 90-100%) and presence of hepatic metastases (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive lower-dose oral capecitabine twice daily on days 1-14.
- Arm II: Patients receive higher-dose oral capecitabine twice daily on days 1-14.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at the end of the third and sixth courses, and at completion of therapy.
PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study within 9 months.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Lancaster, California, United States, 93534
- Antelope Valley Hospital
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Orange, California, United States, 92868
- Medical Oncology Care Associates
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West Covina, California, United States, 91790
- California Cancer Medical Center
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Colorado
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Colorado Springs, Colorado, United States, 80907
- Oncology Clinic, P.C.
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Florida
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Port Saint Lucie, Florida, United States, 34952
- Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
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St. Augustine, Florida, United States, 32086
- North Florida Cancer Center
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Maryland
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Baltimore, Maryland, United States, 21236
- Maryland Hematology/Oncology Associates
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South Carolina
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Charleston, South Carolina, United States, 29403
- Charleston Hematology-Oncology, P.A.
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Tennessee
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Collierville, Tennessee, United States, 38017
- Family Cancer Center
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Utah
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Logan, Utah, United States, 84341
- Logan Regional Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically and/or cytologically confirmed breast cancer
- Advanced and/or metastatic disease
At least 1 measurable lesion
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- No CNS metastases
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Karnofsky 70-100%
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
- Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present OR 10 times ULN if bone metastases present)
- No hepatitis
Renal:
- Creatinine no greater than 1.5 times ULN
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- No clinically significant cardiac disease
- No congestive heart failure
- No symptomatic coronary artery disease
- No cardiac arrhythmias poorly controlled with medication
- No myocardial infarction within the past 12 months even if adequately controlled with medication
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No severe pain inadequately controlled by analgesics
- No prior severe and unexpected reaction to fluoropyrimidine therapy
- No known hypersensitivity to fluorouracil
- No impaired physical integrity of the upper gastrointestinal tract
- No malabsorption syndrome
- No inability to swallow tablets
- No history of uncontrolled seizures, central nervous system disorder, or psychiatric disability that would preclude study participation
- No serious uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 2 but no more than 3 prior chemotherapy regimens
- At least 1 prior chemotherapy regimen containing paclitaxel and an anthracycline as adjuvant therapy or for advanced and/or metastatic disease
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to target lesions unless there is evidence of new disease within the irradiated field
- No concurrent radiotherapy
Surgery:
- No prior organ allografts
Other:
- At least 4 weeks since prior investigational drug
- No concurrent enrollment on other investigational study
- No other concurrent anticancer agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sandy Marcus, Pharmatech Oncology
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000069030
- PHARMATECH-XEL-154
- PHARMATECH-20010330
- ROCHE-PHARMATECH-XEL-154
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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