|
Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer Clinical research trials and Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer. Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer  Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer
Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer
For Condition: stage 3C breast cancer,stage 4 breast cancer,stage 3B breast cancer,stage 3A breast cancer
Status: Suspended
Sponsor(s): Pharmatech Oncology ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SandyMarcus, Study Chair, Pharmatech Oncology
Oncology Clinic, P.C.
Colorado Springs, Colorado, 80907
United States
Logan Regional Hospital
Logan, Utah, 84341
United States
California Cancer Medical Center
West Covina, California, 91790
United States
North Florida Cancer Center
St. Augustine, Florida, 32086
United States
Family Cancer Center
Collierville, Tennessee, 38017
United States
Maryland Hematology/Oncology Associates
Baltimore, Maryland, 21236
United States
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
Port Saint Lucie, Florida, 34952
United States
Antelope Valley Hospital
Lancaster, California, 93534
United States
Charleston Hematology-Oncology, P.A.
Charleston, South Carolina, 29403
United States
Medical Oncology Care Associates
Orange, California, 92868
United States
Additional Information:
Study ID Numbers: CDR0000069030; PHARMATECH-20010330,ROCHE-PHARMATECH-XEL-154,PHARMATECH-XEL-154
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026442
Other Stage 3c Breast Cancer Studies:
1. Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
2. EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
3. Combination Chemotherapy, Monoclonal Antibody Therapy, and Surgery in Treating Women With Stage II, Stage III, or Stage IV Breast Cancer
4. Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer
5. BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Related Studies:
Other stage 3C breast cancer Clinical Trials
Other California Clinical Trials
Other West Covina Clinical Trials
Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer
|
|
|
|
|
|
|
|
