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Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer 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 Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer Clinical research trials and Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer 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 Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer. Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer 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 Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer clinical trial. Subjects frequently get the best healthcare possible for their Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer 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 > "I" Clinical Trials Conditions > Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer  Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer
Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer
For Condition: stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
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 regimens of irinotecan in treating patients who have refractory metastatic breast cancer.
Details: OBJECTIVES: I. Assess the antitumor activity and toxicity of two different schedules of irinotecan in the treatment of patients with refractory metastatic breast cancer who have received 1 or 2 previous chemotherapy regimens (up to one prior therapy for metastatic disease and one for adjuvant therapy). II. Compare the time to progression, survival, and quality of life of these patients on these 2 different schedules of irinotecan. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to dominant disease (visceral vs nonvisceral), performance status (0-1 vs 2), and prior chemotherapy in metastatic setting (yes vs no). Patients assigned to arm I receive irinotecan intravenously over 90 minutes every week for 4 weeks followed by a 2 week rest period. Treatment is repeated every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients assigned to arm II receive irinotecan intravenously over 90 minutes every 3 weeks for 6 weeks. Treatment is repeated every 6 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before and during treatment. Patients are followed every 3 months for 2 years, then annually for 1 year. PROJECTED ACCRUAL: A total of 42-100 patients (21-50 patients per arm) will be accrued for this study within 3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed adenocarcinoma of the breast with progressing locoregional or metastatic disease - Measurable or evaluable indicator lesion - No uncontrolled CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since chemotherapy; No more than 2 prior chemotherapy regimens for metastatic disease; No more than 1 prior chemotherapy regimen in the adjuvant setting; At least 1 prior regimen containing taxane or doxorubicin for metastatic disease or in the adjuvant setting - Endocrine therapy: Not specified - Radiotherapy: No radiotherapy to greater than 25% of bone marrow; No prior treatment with strontium 89 - Surgery: At least 4 weeks since major surgery - Other: No concurrent metoclopramide --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Greater than 3 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 0.3 mg/dL above upper limit of normal (ULN); AST no greater than 3 times ULN - Renal: Creatinine no greater than 1.0 mg/dL above ULN - Cardiovascular: No New York Heart Association class III or IV heart disease - Other: No uncontrolled infection; No chronic debilitating disease; Not pregnant or lactating; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdithPerez, Study Chair, North Central Cancer Treatment Group
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
Additional Information:
Study ID Numbers: CDR0000066332; NCCTG-963255
Study Start Date: August 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003351
Other Stage 4 Breast Cancer Studies:
1. Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer
2. Interleukin-12 in Treating Women With Metastatic Breast Cancer Who Have Received High-Dose Chemotherapy and Peripheral Stem Cell Transplantation
3. Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer
4. Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer
5. Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other South Dakota Clinical Trials
Other Rapid City Clinical Trials
Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer
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