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BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors Clinical research trials and BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors. BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors clinical trial. Human subjects often get the best healthcare available for their BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors  BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors
BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , 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 BMS-247550 with gemcitabine in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose, dose-limiting toxicity, and safety of BMS-247550 when combined with gemcitabine in patients with advanced solid tumors. - Determine the plasma pharmacokinetics of this regimen in this patient population. - Assess, preliminarily, any antitumor activity of this regimen in this patient population. OUTLINE: This is a dose-escalation study of BMS-247550. Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by BMS-247550 IV over 3 hours on day 8. The order of chemotherapy drug administration on day 8 is reversed during the second course only. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 9 patients total are treated at the MTD. PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study within 8-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-hematological cancer that is unresponsive to currently available therapies or for which there is no known effective treatment - Clinical or radiological evidence of disease required - No active brain metastases, including evidence of cerebral edema (by CT scan or MRI), progression from prior imaging study, any requirement for steroids, or clinical symptoms PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin at least 8.0 g/dL Hepatic - Bilirubin no greater than 1.5 mg/dL - ALT and AST no greater than 2.5 times upper limit of normal (ULN) or 93 U/L Renal - Creatinine no greater than 1.5 times ULN or 2.0 mg/dL Other - No documented hypersensitivity reaction to prior paclitaxel or other therapy containing Cremophor EL - No grade 2 or greater pre-existing peripheral neuropathy - No serious uncontrolled medical disorder or active infection that would preclude study therapy - No dementia or altered mental status that would preclude informed consent - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior immunotherapy Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome) - Prior taxanes allowed - Prior adjuvant or neoadjuvant chemotherapy allowed - No more than 2 prior chemotherapy regimens in the metastatic setting - No other concurrent chemotherapy Endocrine therapy - See Disease Characteristics - No concurrent hormonal therapy except hormone-replacement therapy - Concurrent medications to maintain castrate status for progressive hormone-refractory prostate cancer allowed Radiotherapy - At least 4 weeks since prior radiotherapy - No prior radiotherapy to more than 25% of bone marrow - No concurrent radiotherapy Surgery - Not specified Other - At least 4 weeks since prior investigational agents - No other concurrent experimental anticancer medications - No concurrent alternative therapies (e.g., high-dose vitamins or herbal medicines) - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SibylAnderson, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Carol Aghajanian 212-639-2252
Additional Information:
Study ID Numbers: CDR0000256333; MSKCC-02012,NCI-5696
Study Start Date:
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043095
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. CCI-779 in Treating Patients With Advanced Solid Tumors
2. UCN-01 and Cisplatin in Treating Patients With Advanced Solid Tumors
3. BMS-184476 in Treating Patients With Advanced Solid Tumors
4. E7070 in Treating Patients With Solid Tumors
5. Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors
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