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Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery Clinical research trials and Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery. Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery clinical trial. Participants oftentimes recieve the finest healthcare available for their Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery  Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
For Condition: thorax and respiratory cancer,adult solid tumor,Head and Neck Cancer,Breast Cancer,kidney and urinary cancer,male reproductive cancer
Status: Suspended
Sponsor(s): Cancer and Leukemia Group B , 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. St. John's wort may interfere with the effectiveness of chemotherapy. It is not yet known if chemotherapy is more effective with or without St. John's Wort in treating solid tumors. PURPOSE: Randomized phase III trial to compare the effectiveness of docetaxel with or without St. John's wort in treating patients who have solid tumors that cannot be removed by surgery.
Details: OBJECTIVES: - Determine the effect of Hypericum perforatum (St. John's Wort) on the pharmacokinetic clearance of docetaxel in patients with unresectable solid tumors. - Determine the effect of Hypericum perforatum on the production and plasma concentrations of M4-C13-hydroxydocetaxel in these patients. - Determine the effects of this drug on the pharmacodynamics of docetaxel in these patients. - Determine the relationship between the effects of this drug on docetaxel metabolic clearance and CYP3A4/CYP3A5 genotype in these patients. - Determine the relationship between the effect of this drug on docetaxel metabolic clearance and p-glycoprotein genotype in these patients. - Determine the relationship between the effect of this drug on docetaxel clearance and pregnane receptor genotype in these patients. - Assess compliance with this drug in these patients. - Assess the steady state concentrations of hyperforin, one of the putative psychoactive components of Hypericum perforatum, in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients who have not been receiving chronic Hypericum perforatum (St. John's Wort) are assigned to group A, while a cohort of 8 patients who have been receiving chronic Hypericum perforatum are assigned to group B. - Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral placebo three times daily on days 1-14 and docetaxel IV over 1 hour on day 15. - Arm II: Patients receive oral Hypericum perforatum three times daily on days 1-14 and docetaxel as in arm I. - Group B (non-randomized group): Patients receive docetaxel as in arm I and continue to receive their chronic regimen of Hypericum perforatum except on day 15. Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for new primaries and survival only. PROJECTED ACCRUAL: Approximately 92 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed unresectable solid tumor, including, but not limited to, the following: - Lung cancer - Breast cancer - Head and neck cancer - Bladder cancer - Prostate cancer - Must be suitable for treatment with single-agent docetaxel - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Male or female Menopausal status: - Not specified Performance status: - CTC 0-2 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than upper limit of normal (ULN) - Alkaline phosphatase less than 2.5 times ULN Renal: - Creatinine no greater than 1.5 times ULN - BUN no greater than 1.5 times ULN Other: - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior bone marrow transplantation - No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No prior docetaxel - No more than 2 prior chemotherapy regimens - No other concurrent chemotherapy Endocrine therapy: - No concurrent hormonal agents except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes) Radiotherapy: - At least 3 weeks since prior radiotherapy - No concurrent palliative radiotherapy Surgery: - At least 4 weeks since prior major surgery Other: - At least 6 months since prior Hypericum perforatum (St. John's Wort) - At least 1 week since prior CYP3A enzyme inducers including: - Phenobarbital - Phenytoin - Carbamazepine - Lamotrigine - Rifampin - Rifabutin - Isoniazid - Sulfinpyrazone - Pioglitazone - Anti-HIV drugs such as efavirenz or nevirapine - At least 1 week since prior CYP3A enzyme inhibitors including: - Erythromycin - Clarithromycin - Azithromycin - Roxithromycin - Ketoconazole - Fluconazole - Itraconazole - Metronidazole - Chloramphenicol - Ritonavir - Saquinavir - Indinavir - Nelfinavir mesylate - Delavirdine - Amiodarone - Cyclosporine - Tacrolimus - Sirolimus - Nefazodone - Fluvoxamine - No concurrent CYP3A enzyme inducers - No concurrent CYP3A enzyme inhibitors - No ethanol (especially red wine), grape fruit juice, or seville orange juice (CYP3A enzyme inhibitor) within 3 days before or after receiving docetaxel
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LionelLewis, Study Chair, Norris Cotton Cancer Center
Additional Information:
Study ID Numbers: CDR0000069449; CLB-60002
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041171
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Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
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