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Home > "D" Clinical Trials Conditions > Docetaxel and Flavopiridol to Treat Breast Cancer  Docetaxel and Flavopiridol to Treat Breast Cancer
Docetaxel and Flavopiridol to Treat Breast Cancer
For Condition: Breast Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will examine the safety and effectiveness of the anticancer drugs flavopiridol and docetaxel used in combination to treat breast cancer. Docetaxel has been used to treat many cancer patients. The addition of flavopiridol may enhance the effects of docetaxel on cancer cells. Patients 18 years of age or older with stage III or stage IV breast cancer who have not been successfully treated with other therapies may be eligible for this study. Before starting treatment, patients will undergo a history and physical examination, blood tests, EKG, MUGA, tumor biopsy (if reachable), x-rays, CT scans, and PET scans. These tests and procedures are described below. Patients will also be asked to fill out a quality of life questionnaire. Participants will be admitted to the hospital for 4 to 6 days to receive their first treatment. Subsequent treatments may be administered on an outpatient basis if approved by the doctor. Before starting therapy, patients will have a central venous catheter put in place. This is a small plastic tube that is placed in a vein in the chest through which chemotherapy is administered. The tube remains in place throughout treatment. On day 1, docetaxel will be given intravenously (through a vein) over a 1-hour period. Flavopiridol will be started on day 2 and will continue for 3 days. It will be given through a small portable battery-powered pump worn around the waist or over the shoulder. No drug will be given days 5 through 21. This completes one 21-day treatment cycle. Patients may continue treatment cycles as long as they do not have serious side effects and their tumors remain stable or shrink. In addition to drug treatment, patients will undergo the following tests and procedures. They will be done at the start of the study and at the intervals noted below: 1. Blood tests are done before every treatment cycle to check blood counts, and liver and kidney functions. 2. Blood will also be drawn for research purposes at certain times. 3. If reachable, tumor biopsies are done on days 1, 2 and 5 of the first cycle only. 4. An electrocardiogram (EKG) and MUGA scan (special x-ray of the heart) are done prior to the first treatment to test heart function. 5. Scans and x-rays will be done every 3 treatment cycles (about 9 weeks). These tests may include a chest x-ray, computed tomography (CT) scans of the head, chest, abdomen, and pelvis, bone scan, and others as necessary. 6. Positron emission tomography (PET) scans are done every 3 treatment cycles. The patient receives an injection of a small amount of radioactive substance (radioactive glucose, water, or some type of medicine) and lies on a table while a special camera produces images of how the body uses the substance. This provides information about the body's chemistry. 7. Quality of life questionnaires are completed at certain times. Patients will answer questions about their physical, social, emotional, and functional well-being. Patients will keep a diary of the kind of side effects they have and their duration.
Details: This study is a Phase I/II in patients with stage III or IV previously treated breast cancer. Patients will have been previously treated with a taxane and an anthracycline. The initial part of the study will be a dose escalation of docetaxel followed 24 hours later by a fixed dose of 72 hours infusion of flavopiridol, a cyclin-dependent kinase inhibitor. After the MTD of docetaxel has been determined, the dose of flavopiridol will be escalated up to two more dose levels. As of September 24, 2001, the study will be a dose escalation of flavopiridol as a daily 1 hour infusion for 3 days starting 24 hours after the administration of docetaxel. The final MTD of flavopiridol will be given following docetaxel as the Phase II dose. The objective of the Phase II portion of the study will be to determine whether the response rate is increased from 18% with docetaxel alone to 35% with the two drugs. Pharmacokinetics will be obtained at all dose levels. Translational endpoints include measurement by immunohistochemistry of cyclin D1, p53, bcl2, ki67-mib1, mitosis, and apoptosis from paired tumor samples before and after treatment when possible and also measurement of these parameters in buccal mucosa as a normal surrogate tissue when possible. Also, positron emission tomography (PET) will be performed to assess the ability to measure tumor response. Flow cytometric analyses will be performed to determine the effect of multiple cycles of docetaxel/flavopiridol therapy on lymphocyte subpopulations, including T-cell activation/memory subsets and NK/LAK functional subsets. Quality of life will be assessed by FACT-B. Thrombosis factors will be measured at baseline and after treatment since a previous Phase II study has shown a high incidence of thrombosis.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must have a histologically confirmed adenocarcinoma of the breast. Patients may have evaluable disease for the phase I portion only. At least one site of measurable State III or Stage IV disease for the phase II portion. Measurements must be obtained prior to study entry. Age greater than or equal to 18 years. Women of childbearing potential must agree to use an accepted and effective method of contraception during their participation on the trial. Patients could have received an unlimited number of prior therapies for the treatment of their metastatic carcinoma of the breast for the phase I portion and may have received no more than two prior chemotherapy regimens for the treatment of their metastatic carcinoma of the breast for the phase II portion. If the patient has had prior adjuvant chemotherapy within 6 months of diagnosis of their metastatic disease, this will be considered to be chemotherapy for advance disease (prior hormonal therapy in either a metastatic or adjuvant setting is allowed). ECOG performance status of 0, 1, or 2. Patients must have a left ventricular ejection fraction of greater than or equal to 50% without clinical signs or symptoms of heart failure. Patients must have adequate bone marrow, hepatic, and renal function defined by the following: Granulocytes greater than or equal to 1500/mm(3) Platelets greater than or equal to 100,000/mm(3) Serum creatinine less than or equal to 1.5 mg/dL SGOT less than or equal to 1.5 x upper limit of normal Total bilirubin less than or equal to upper limit of normal for institution Alkaline phosphatase less than or equal to 2.5 x upper limit of normal Patients receiving hormonal therapy must discontinue these medications 2 weeks prior to study entry and not show evidence of disease improvement, after withdrawal from hormonal therapy as evaluated by radiographic tests. The interval between prior chemotherapy and this therapy should be greater than or equal to 4 weeks, greater than or equal to 6 weeks for nitrosourea, and greater than or equal to 8 weeks for UCN-01, and patients must have recovered from prior toxicities. EXCLUSION CRITERIA: Any patient may be excluded from this study at the discretion of the Principal Investigator if it is deemed that their participation would represent an unacceptable medical or psychiatric risk. Patients must not have had an active malignancy other than breast cancer, in situ carcinoma of the cervix, or non-melanomatous skin cancers in the past 5 years. Chemotherapy less than 4 weeks prior to enrollment. Previous flavopiridol treatment. Pregnant or lactating women. Evidence of carcinomatous meningitis or brain metastases. Grade 2 or greater peripheral neuropathy. Patients with active coagulopathy requiring therapeutic anticoagulation. Patients with uncontrolled hypertension (sustained systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 100 mmHg), uncontrolled cardiac arrhythmia, diabetes mellitus with a fasting blood sugar greater than 200 mg%, prior history of myocardial infarction within 12 months prior to study, significant ischemia, or valvular heart disease. Active, unresolved infection. Serious intercurrent medical illness. Patients receiving other investigational drugs. Patients with Gilbert's disease. Patients with a history of hypersensitivity reaction to products containing Polysorbate 80 (Tween 80).
Total Enrollment: 49
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000212; 00-C-0212
Study Start Date: September 12, 2000
Record last reviewed: April 18, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006277
Other Breast Cancer Studies:
1. Primary Chemotherapy with Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer
2. Comparison of Two Types of Biopsy in Patients With Breast Lesions That Cannot Be Felt Upon Examination
3. Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced or Metastatic Breast Cancer
4. Comparison of Antibody Therapies in Treating Patients With Graft- Versus-Host Disease That Does Not Respond to Steroid Therapy
5. Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors
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Docetaxel and Flavopiridol to Treat Breast Cancer
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