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SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer Clinical research trials and SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer. SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer clinical trial. Participants typically obtain the most effective healthcare available for their SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer  SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
For Condition: stage 3B breast cancer,Male Breast Cancer,stage 4 breast cancer,inflammatory breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: SU5416 may stop the growth of breast cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining SU5416 and doxorubicin in treating patients who have stage IIIB or stage IV inflammatory breast cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of SU5416 and doxorubicin in patients with stage IIIB or IV inflammatory breast cancer. - Determine the overall response, response rate, and progression-free survival rate of patients treated with this regimen. - Determine the antiangiogenic effects of this regimen in these patients. - Assess the relationship of plasma levels of these drugs with safety and efficacy in these patients. OUTLINE: This is a dose-escalation study. Patients receive doxorubicin IV continuously over 72 hours on days 1-3 of course 1. For all subsequent courses, patients receive doxorubicin as in course 1 and SU5416 IV over 1 hour twice weekly (on days 1 and 4) beginning on week 2 of course 2. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity. After chemotherapy, all patients undergo a modified radical mastectomy and radiotherapy to the chest wall and regional lymph nodes. Patients with estrogen or progesterone receptor positive disease receive oral tamoxifen for 5 years after radiotherapy. Cohorts of 3-6 patients receive escalating doses of SU5416 and doxorubicin 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. Once the MTD is determined, an additional 3 patients may be treated at that dose level. Patients are followed every 3 months until disease progression. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 6-9 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed stage IIIB or IV (supraclavicular lymph node involvement or metastasis) inflammatory breast cancer - Primary or secondary - No brain metastases or primary brain tumors - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Male or female Menopausal status: - Not specified Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - WBC at least 3,500/mm^3 - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin greater than 9.0 g/dL Hepatic: - Bilirubin normal - AST and ALT less than 2 times upper limit of normal - PT and PTT normal OR - INR less than 1.1 Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - LVEF at least 50% by MUGA - No New York Heart Association class III or IV heart disease - No uncompensated coronary artery disease - No myocardial infarction or unstable angina within the past 6 months - No deep venous or arterial thrombosis within the past 3 months Pulmonary: - No history of pulmonary embolism within the past 3 months Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No history of diabetes mellitus with severe peripheral vascular disease - No other prior or concurrent malignancies within the past 10 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix - No other uncontrolled illnesses PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent epoetin alfa or filgrastim (G-CSF) Chemotherapy: - No more than 2 prior chemotherapy regimens allowed - No prior doxorubicin or other anthracycline Endocrine therapy: - Not specified Radiotherapy: - Prior radiotherapy allowed Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BethOvermoyer, Study Chair, Ireland Cancer Center
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Additional Information:
Study ID Numbers: CDR0000067829; CWRU-5199,NCI-T99-0099
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005822
Other Inflammatory Breast Cancer Studies:
1. Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer
2. Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer
3. Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer
4. Trastuzumab Plus Paclitaxel in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
5. Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer
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SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
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