|
Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer Clinical research trials and Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer. Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "I" Clinical Trials Conditions > Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer  Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer
Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: Recruiting
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may help capecitabine kill more cancer cells by making tumor cells more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with capecitabine in treating women who have advanced breast cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of capecitabine and irinotecan in women with advanced breast cancer. - Determine the degree of accumulation of cells in S-phase in tumor biopsies from patients treated with this regimen. - Determine the dose-limiting toxicity and other major or unusual toxic effects of this regimen in these patients. - Determine any antitumor activity of this regimen in these patients. - Determine the pharmacokinetics of this regimen, including the active metabolite SN-38, in these patients. - Correlate pharmacokinetic parameters of this regimen with the biological changes observed in these patients. - Determine, preliminarily, the relationship of tumor response with modulation of S-phase in patients treated with this regimen. OUTLINE: This is a dose-escalation study. Patients receive irinotecan IV over 1.5 hours on days 1, 8, 22, and 29 and oral capecitabine twice daily on days 1-14 and 23-36. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 8-37 patients will be accrued for this study within 18-24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of breast cancer not eligible for potentially curative therapy or studies of higher priority - Advanced disease - Tumor accessible to biopsy AND not irradiated - Failed at least 1 prior chemotherapy regimen (not including adjuvant chemotherapy) - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 - Hemoglobin 9.0 g/dL Hepatic - AST 2 times upper limit of normal (ULN) - Bilirubin 1.5 times ULN Renal - Creatinine 1.5 times ULN OR - Creatinine clearance 50 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No active uncontrolled bacterial, viral, or fungal infection - No poor medical risk from non-malignant systemic disease PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - Prior irinotecan allowed - Prior carboplatin allowed - More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - More than 4 weeks since prior radiotherapy except for small port radiotherapy for local control Surgery - More than 4 weeks since prior major surgery Other - No concurrent high-dose IV cyclosporine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TraceyO'Connor, Principal Investigator, Roswell Park Cancer Institute
Roswell Park Cancer Institute *Recruiting*
Buffalo, New York, 14263-0001
United States
Recruiting Tracey O'Connor 716-845-7614
Additional Information:
Study ID Numbers: CDR0000363790; RPCI-RP-0221
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083148
Other Stage 4 Breast Cancer Studies:
1. Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer
2. T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer
3. Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy
4. Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer
5. Chemotherapy With or Without Monoclonal Antibody in Treating Women With Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer
|
|
|
|
|
|
|
|
