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Home > "B" Clinical Trials Conditions > BMS-247550 Plus Carboplatin in Treating Patients With Recurrent or Refractory Solid Tumors  BMS-247550 Plus Carboplatin in Treating Patients With Recurrent or Refractory Solid Tumors
BMS-247550 Plus Carboplatin in Treating Patients With Recurrent or Refractory Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): H. Lee Moffitt Cancer Center and Research 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 BMS-247550 and carboplatin in treating patients who have recurrent or refractorysolid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of BMS-247550 when given in combination with carboplatin in patients with recurrent or refractory solid tumors. - Determine the dose-limiting toxicity and safety of this regimen in these patients. - Determine the plasma pharmacokinetics of this regimen in these patients. - Determine, preliminarily, any antitumor activity of this regimen in these patients. - Correlate the protein expression of survivin with the expression of other apoptotic regulators, the apoptotic index, and response in patients treated with this regimen. OUTLINE: This is a dose-escalation study of BMS-247550. Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15 followed by carboplatin IV over 1 hour on day 1. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR or up to a total of 6 courses. The first two cohorts of 3-6 patients each 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 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). The third and fourth cohorts of 10 patients each receive escalating doses of BMS-247550 until the MTD is determined. The MTD is defined as the dose preceding that at which at least 3 of 10 patients experience DLT. Once the MTD is determined for the third and fourth cohorts, 15 additional patients are treated at the MTD. Patients are followed for 30 days. PROJECTED ACCRUAL: Approximately 18-45 patients will be accrued for this study within 6-15 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 for which standard curative or palliative measures do not exist or are no longer effective - Measurable or evaluable disease - Lesion accessible for core or excisional biopsy if being treated at the maximum tolerated dose (MTD) - No biliary tract dilation if radiologically guided biopsy of the liver is planned - No requirement for core biopsy of lung lesion that is not pleural based - No requirement for laparotomy or thoracotomy solely for biopsy - No medical condition that would preclude biopsy - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 - ECOG 0-1 if being treated at the MTD Life expectancy: - More than 3 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No prior bleeding disorder or unexplained bleeding if being treated at the MTD Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST/ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) - PT/PTT normal Renal: - Creatinine no greater than 1.5 times ULN 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 - No other concurrent uncontrolled illness that would preclude study participation - No ongoing or active infection - No grade 2 or greater neuropathy (sensory or motor) - No prior severe allergic reaction attributable to compounds containing Cremophor EL or platinum agents - No psychiatric illness or social situation that would preclude study compliance - No medical condition that would preclude study if being treated at the MTD PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 week since prior immunotherapy - At least 24 hours since prior growth factors Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No prior epothilone agents Endocrine therapy: - At least 1 week since prior hormonal therapy directed at malignancy - Concurrent hormone replacement therapy allowed Radiotherapy: - At least 4 weeks since prior wide-field radiotherapy involving 30% or more of bone marrow Surgery: - See Disease Characteristics Other: - At least 4 weeks since prior investigational agents - No prior or concurrent St. John's Wort - No concurrent combination anti-retroviral therapy for HIV-positive patients - No other concurrent investigational agents - No concurrent heparin or other anticoagulants if being treated at the MTD
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DanielSullivan, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Additional Information:
Study ID Numbers: CDR0000069105; NCI-5306,MCC-12657
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028561
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Erlotinib and Irinotecan in Treating Patients With Advanced Solid Tumors
2. Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy
3. Cisplatin Plus Bryostatin 1 in Treating Patients With Advanced Cancer
4. SU6668 in Treating Patients With Advanced Solid Tumors
5. UCN-01 and Cisplatin in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
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BMS-247550 Plus Carboplatin in Treating Patients With Recurrent or Refractory Solid Tumors
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