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Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer Clinical research trials and Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer. Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer  Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer
Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Some tumors become resistant to chemotherapy drugs. Combining PSC 833 with a chemotherapy drug may reduce resistance to the drug, and allow the tumor cells to be killed. PURPOSE: Phase II trial to study the effectiveness of PSC 883 and paclitaxel in treating women who have recurrent or metastatic breast cancer.
Details: OBJECTIVES: I. Evaluate the antitumor activity, as measured by frequency of objective response and time to progression, of the multidrug resistance modulator PSC 833 in combination with paclitaxel in women with recurrent or metastatic breast cancer. II. Describe the toxicity of this regimen. PROTOCOL OUTLINE: All patients receive PSC 833 by mouth every 6 hours for a total of 12 doses. Paclitaxel is infused over 3 hours, after the 5th dose of PSC 833. Treatment is repeated every 3 weeks in stable and responding patients. PSC 833 must not be mixed with grapefruit juice. Growth factors may be used at the discretion of the investigator. Patients are followed every 3 months for the first two years, then every 6 months for years 2-5, and then annually thereafter. PROJECTED ACCRUAL: It is anticipated that approximately 36 patients will be entered over 24 months if there are at least 6 responses in the first 17 patients.
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 that is recurrent or metastatic; No CNS metastases - Bidimensionally measurable disease required - Patients with bone sites only are not eligible - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Prior anthracyclines or medical contraindication to anthracycline therapy required; No prior paclitaxel or taxotere; No more than 1 prior regimen for metastatic or recurrent disease; Adjuvant chemotherapy within 6 months of diagnosis of metastatic disease considered therapy for advanced disease; At least 3 weeks since chemotherapy - Endocrine therapy: At least 3 weeks since hormonal therapy for metastases - Radiotherapy: Not specified - Surgery: Not specified - Other: No concurrent treatment with any of the following agents proven to affect blood levels of cyclosporine: Diltiazem; Nicardipine; Verapamil; Fluconazole; Itraconazole; Ketoconazole Clarithromycin; Erythromycin; Methylprednisolone; Prednisolone; Allopurinol; Bromocriptine; Danazol; Metoclopramide; Nafcillin; Rifampin; Carbamazepine; Phenobarbital; Phenytoin; Octreotide; Ticlopidine --Patient Characteristics-- - Age: 18 and over - Sex: Women only - Menopausal status: Not specified - Performance status: ECOG 0-2 - Hematopoietic: Platelet count at least 100,000/mm3; Absolute granulocyte count at least 1,500/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; AST less than 2.5 times upper limit of normal - Renal: Creatinine no greater than twice upper limit of normal - Other: No allergy to cyclosporine or to drugs formulated with Cremophor (e.g., some anesthetics and muscle relaxants); No active unresolved infection; More than 7 days since parenteral antibiotics; No second malignancy within 5 years except: In situ cervical cancer Nonmelanomatous skin cancer; No pregnant or nursing women; Adequate contraception required of fertile women
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertCarlson, Study Chair, Eastern Cooperative Oncology Group
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Kimball Medical Center
Lakewood, New Jersey, 08701
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304
United States
St. Francis Medical Center
Trenton, New Jersey, 08629
United States
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Hunterdon Regional Cancer Program
Flemington, New Jersey, 08822
United States
Additional Information:
Study ID Numbers: CDR0000065011; E-1195
Study Start Date: June 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002826
Other Recurrent Breast Cancer Studies:
1. PS-341 in Treating Women With Metastatic Breast Cancer
2. Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy
3. Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
4. Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
5. Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
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Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer
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