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Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV 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 Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV Breast Cancer Clinical research trials and Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV 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 Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV Breast Cancer. Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV 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 Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV Breast Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV 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 > Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV Breast Cancer  Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV Breast Cancer
Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV Breast Cancer
For Condition: recurrent breast cancer,stage 3B breast cancer,stage 4 breast cancer
Status: Recruiting
Sponsor(s): Arthur G. James Cancer Hospital & Richard J. Solove Research Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Suramin may increase the effectiveness of paclitaxel by making tumor cells more sensitive to the drug. PURPOSE: Phase I/II trial to study the effectiveness of combining suramin with paclitaxel in treating women who have stage IIIB or stage IV breast cancer.
Details: OBJECTIVES: Phase I - Determine the dose of suramin in combination with paclitaxel (TXT) that results in suramin plasma concentrations approaching 10-50 µM over the duration, when TXT in the plasma is at therapeutically significant levels, in women with stage IIIB or IV breast cancer. - Determine the pharmacokinetics of low-dose suramin in these patients. Phase II - Determine the objective response rate in patients treated with this regimen. - Determine the time to tumor progression in patients treated with this regimen. - Determine the 1-year survival of patients treated with this regimen. OUTLINE: This is a phase I, dose-escalation study of suramin followed by a phase II multicenter study. - Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 µM over the duration when paclitaxel levels are therapeutic. - Phase II: Patients receive paclitaxel in combination with the target dose of suramin as above. PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for the phase I study within 9 months. A total of 28-39 patients will be accrued for the phase II study within 7-10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed advanced breast cancer - Stage IIIB or IV - Measurable disease (phase II) - Must have received prior paclitaxel or other taxanes in the adjuvant or metastatic setting - Prior treatment with anthracyclines is not required - No known brain metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9.0 g/dL Hepatic - Bilirubin no greater than 1.5 mg/dL - AST/ALT no greater than 2.5 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - LVEF at least lower limit of normal - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No history of allergic reactions attributable to compounds of similar chemical or biological composition to Cremophor - No concurrent uncontrolled illness that would preclude study compliance - No ongoing or active infection - No uncontrolled diabetes mellitus - No psychiatric illness or social situations that would preclude study compliance - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No more than 2 prior chemotherapy regimens for this malignancy (phase II) Endocrine therapy - No concurrent steroids or hormones except the following: - Steroids to prevent hypersensitivity reactions prior to paclitaxel administration - Hormones for nondisease-related conditions (e.g., insulin for diabetes) Radiotherapy - At least 3 weeks since prior radiotherapy and recovered Surgery - At least 3 weeks since prior surgery and recovered Other - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational agents - Concurrent bisphosphonates (i.e., pamidronate or zoledronate) are allowed for the treatment of hypercalcemia or palliation of skeletal metastases
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesShapiro, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Charles Shapiro 614-293-7507
Additional Information:
Study ID Numbers: CDR0000269707; OSU-02H0216,OSU-0216,NCI-5851
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054028
Other Stage 4 Breast Cancer Studies:
1. Combination Chemotherapy in Treating Women With Breast Cancer
2. Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer
3. Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer
4. Chemotherapy in Treating Patients With Breast Cancer
5. Combination Chemotherapy in Treating Women With Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV Breast Cancer
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