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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 is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer conditions. Clinical Trials Search.org is a site devoted 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 medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like 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 for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated 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. Test subjects typically obtain the finest healthcare available for their SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict 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 Male Breast Cancer Studies:
1. Enhanced Ultrasound in Determining Extent of Disease in Women With Primary Breast Cancer
2. Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer
3. Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer
4. Two Dose Levels of Capecitabine With Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer Who Have Not Responded to Previous Anthracycline-Based Chemotherapy
5. Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III 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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