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Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors Clinical research trials and Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors healthcare trials happen in many of places across 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 effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors. Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors  Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors
Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with docetaxel may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining bortezomib with docetaxel in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of bortezomib and docetaxel in patients with advanced solid tumors. - Determine the toxicity and tolerability of this regimen in these patients. - Determine the biologic correlates of proteasome inhibition of bortezomib and determine the effects of this inhibition on the pharmacokinetics of docetaxel in these patients. - Determine the antitumor efficacy of this regimen in these patients. OUTLINE: This is a dose-escalation study. For course 1, patients receive docetaxel IV over 1 hour on days 1 and 8 and bortezomib IV over 3-5 seconds on days 9 and 12. Patients then receive 1 week of rest. For course 2 and all subsequent courses, patients receive docetaxel on days 1 and 8 and bortezomib on days 2, 5, 9, and 12. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 2-6 patients receive escalating doses of bortezomib and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. PROJECTED ACCRUAL: A minimum of 24 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 solid tumor for which standard curative or palliative measures do not exist or are no longer effective - Metastatic or unresectable disease - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 50-100% Life expectancy - More than 12 weeks Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 8 g/dL Hepatic - Bilirubin normal - AST and ALT no greater than 1.5 times upper limit of normal (ULN) and alkaline phosphatase no greater than 2.5 times ULN OR - Alkaline phosphatase no greater than 5 times ULN (unless bone-derived) and AST and ALT less than 1.5 times ULN Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - 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 during and for 3 months after study - No prior allergic reactions attributed to taxanes (e.g., docetaxel or paclitaxel) or compounds of similar chemical or biological composition - No prior allergic reactions to compounds similar to bortezomib or other study agents - No known hypersensitivity to corticosteroids - No predicted intolerance to regular, repeated administration of corticosteroids (e.g., poorly controlled diabetes or significant osteoporosis/osteopenia) - No ongoing or active infection - No other uncontrolled concurrent illness that would preclude study participation - No psychiatric illness or social situation that would preclude study participation - No peripheral neuropathy grade 2 or greater PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for carmustine, nitrosoureas, or mitomycin) and recovered - No more than 3 courses of mitomycin - Prior taxanes allowed - At least 6 months since prior docetaxel administered on a weekly schedule Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior radiotherapy and recovered Surgery - Not specified Other - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent anticancer agents or therapies (commercial or investigational)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeborahArmstrong, Study Chair, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-1000
United States
Additional Information:
Study ID Numbers: CDR0000257807; NCI-1858,JHOC-J0203
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049088
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor
2. Irinotecan in Treating Aging Patients With Solid Tumors
3. Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer
4. Vaccine Therapy in Treating Patients With Advanced Cancer
5. Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy
Related Studies:
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Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors
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