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Home > "P" Clinical Trials Conditions > Paclitaxel and BMS-214662 in Treating Patients With Advanced Solid Tumors  Paclitaxel and BMS-214662 in Treating Patients With Advanced Solid Tumors
Paclitaxel and BMS-214662 in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Ireland Cancer Center
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 paclitaxel and BMS-214662 in treating patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of BMS-214662 in combination with paclitaxel in patients with advanced solid tumors. II. Determine the safety and tolerability of this regimen in these patients. III. Determine the pharmacokinetics of this treatment regimen in this patient population. IV. Determine the pharmacodynamic effects of this treatment regimen in serial tumor biopsies in these patients. V. Determine the cytotoxicity of this treatment regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation study of BMS-214662. Patients receive paclitaxel IV over 3 hours on day 1 and BMS-214662 IV over 1 hour on day 3 of course 1. For all subsequent courses, patients receive paclitaxel IV over 3 hours followed 30 minutes later by BMS-214662 IV over 1 hour on day 1. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or objectively responding disease receive additional therapy at the investigator's discretion. Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed every 4 weeks. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 12-15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed nonhematologic malignancy unresponsive to standard therapy or for which no effective therapy exists - Measurable or evaluable disease amenable to CT guided or percutaneous needle biopsy - No active, symptomatic brain metastases requiring steroids, including evidence of cerebral edema on CT scan or MRI or progression from prior imaging study --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy - Chemotherapy: No more than 2 prior chemotherapy regimens; Prior taxanes allowed; At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin); No other concurrent chemotherapy - Endocrine therapy: See Disease Characteristics; No concurrent antineoplastic hormonal therapy Concurrent hormonal replacement therapy allowed - Radiotherapy: At least 4 weeks since prior wide field radiotherapy; No concurrent radiotherapy - Surgery: Not specified - Other: At least 4 weeks since prior investigational drugs; No other concurrent experimental anticancer medications; At least 7 days since prior substrates of cytochrome P450-3A4 (CYP3A4) --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/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; ALT/AST no greater than 2.5 times upper limit of normal (ULN) - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No uncontrolled or significant cardiovascular disease; No myocardial infarction within the past 6 months; No significant congestive heart failure; No second or third degree heart block; No prolonged QTc interval (greater than 450 ms) on electrocardiogram - Pulmonary: No uncontrolled or significant pulmonary disease - Other: No serious uncontrollable medical disorder or active infection that would preclude study; No dementia or altered mental status that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
VinitMakkar, Study Chair, Ireland Cancer Center
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Additional Information:
Study ID Numbers: CDR0000068027; NCI-290,CWRU-4Y99
Study Start Date: January 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006018
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
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2. Radiofrequency Ablation in Treating Patients With Bone Metastases
3. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
4. Study to Assess Cancer Patients' Satisfaction With Hospital Quality of Care
5. Lidocaine Patch in Treating Cancer Patients with Neuropathic Pain After Surgery
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Paclitaxel and BMS-214662 in Treating Patients With Advanced Solid Tumors
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