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Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors Clinical research trials and Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors. Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors clinical trial. Human subjects frequently get the finest healthcare available for their Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.

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Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors



Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors

For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): Barbara Ann Karmanos Cancer 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol and docetaxel in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the dose-limiting toxic effects and maximum tolerated dose of flavopiridol and docetaxel in patients with advanced solid tumors. - Determine the objective response rate and duration of response in patients treated with this regimen. - Determine the pharmacokinetics of these drugs in this patient population. OUTLINE: This is a dose-escalation study. Patients receive docetaxel IV over 60 minutes on day 1 and flavopiridol IV continuously over 24 hours on day 2. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of docetaxel and flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 9-11 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed metastatic or unresectable solid tumor - No standard relatively effective curative or palliative measures exist - Measurable disease in at least 1 dimension - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - No known clinically active and uncontrolled brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 - Karnofsky 60-100% 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 Hepatic: - Bilirubin normal - ALT/AST no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN Renal: - Creatinine normal Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - No prior allergic reactions to compounds of similar chemical or biologic composition to flavopiridol or docetaxel - No other uncontrolled concurrent illness that would preclude study participation - No ongoing or active infection - No psychiatric illness or social situations that would preclude study compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunotherapy Chemotherapy: - At least 6 months since prior taxane therapy - At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No other concurrent chemotherapy Endocrine therapy: - No concurrent hormonal therapy except contraceptives, appetite stimulants, or replacement steroids Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy Surgery: - See Disease Characteristics Other: - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PhilipPhilip,  Study Chair,  Barbara Ann Karmanos Cancer Institute

Barbara Ann Karmanos Cancer Institute
Detroit,  Michigan,  48201-1379
United States
 


Additional Information:
Study ID Numbers:  CDR0000068605;  WSU-C-2197,NCI-1610
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016185

Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
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3. Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases

4. CHS 828 in Treating Patients With Solid Tumors

5. Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors

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