BMS-247550 in Treating Patients With Cancers That Have Not Responded to Previous Therapy
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|ClinicalTrials.gov Identifier: NCT00020371|
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : April 28, 2015
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have cancers that have not responded to previous therapy.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific Neutropenia||Drug: BMS-247550 Drug: filgrastim||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose, dose-limiting toxic effects, and recommended phase II dose of BMS-247550 in patients with refractory neoplasms.
II. Evaluate the pharmacokinetics and pharmacodynamics of this drug in these patients.
III. Determine the occurrence of response in patients treated with this drug.
PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive BMS-247550 IV over 1 hour on days 1-5. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 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 (DLT). Once the MTD is determined, additional patients are accrued to receive BMS-247550 at the recommended phase II dose.
If neutropenia is identified as the DLT, a second dose escalation is performed to identify the MTD of BMS-247550 with the addition of filgrastim (G-CSF) in cohorts as above. Patients receive fixed-dose G-CSF 72 hours after final BMS-247550 dose, and continuing until blood levels return to normal.
A total of 45 patients will be accrued for this study within 12-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Study of BMS-247550 in Patients With Refractory Neoplasms|
|Study Start Date :||September 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020371
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Jame Abraham||National Cancer Institute (NCI)|