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Home > "D" Clinical Trials Conditions > Docetaxel and Carboplatin in Treating Women With Metastatic Breast Cancer  Docetaxel and Carboplatin in Treating Women With Metastatic Breast Cancer
Docetaxel and Carboplatin in Treating Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent 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. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating women who have metastatic breast cancer.
Details: OBJECTIVES: I. Determine the anti-tumor activity of docetaxel and carboplatin in patients with metastatic adenocarcinoma of the breast. II. Determine the objective response rate, time to progression, and survival in patients treated with this regimen. III. Determine the toxic effects of this regimen in these patients. IV. Assess the common functional polymorphisms in genes involved in chemotherapeutic response to improve prediction of clinical outcomes and provide insight into the potential for genotype-specific drug dosage. PROTOCOL OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD), partial response (PR), or complete response (CR) may receive 4 additional courses past SD, PR, or CR. Patients are followed every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: A maximum of 55 patients will be accrued for this study within 11 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven metastatic adenocarcinoma of the breast - Measurable disease; At least 20 mm in at least 1 dimension - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent prophylactic filgrastim (G-CSF) during the first course of study therapy - Chemotherapy: No prior chemotherapy for metastatic disease; Prior adjuvant chemotherapy allowed; More than 1 year since prior paclitaxel, docetaxel, cisplatin, or carboplatin; No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy to breast, chest wall, or axilla; No prior radiotherapy to greater than 30% of bone marrow; No concurrent radiotherapy - Surgery: At least 4 weeks since prior major surgery and recovered - Other: More than 7 days since prior IV antibiotics; No concurrent experimental drugs --Patient Characteristics-- - Age: 18 and over - Sex: Female - Menopausal status: Not specified - Performance status: ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than upper limit of normal (ULN); SGOT/SGPT no greater than 2.5 times ULN; Alkaline phosphatase no greater than ULN OR SGOT/SGPT no greater than ULN; Alkaline phosphatase no greater than 4 times ULN - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No myocardial infarction within the past 6 months; No congestive heart failure; No unstable angina; No clinically significant pericardial effusion or arrhythmia - Other: No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix; No active unresolved infection; No prior hypersensitivity reaction to docetaxel; No grade 2 or greater sensory or motor neuropathy; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdithPerez, Study Chair, North Central Cancer Treatment Group
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
Additional Information:
Study ID Numbers: CDR0000067945; NCCTG-N9932
Study Start Date: November 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005963
Other Stage 4 Breast Cancer Studies:
1. Vaccine Therapy in Treating Patients With Breast Cancer
2. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Advanced Breast Cancer
3. Chemotherapy in Treating Women With Metastatic Breast Cancer
4. Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
5. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other North Dakota Clinical Trials
Other Fargo Clinical Trials
Docetaxel and Carboplatin in Treating Women With Metastatic Breast Cancer
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