BMS-247550 in Treating Patients With Advanced Cancers

Tracking Information
First Submitted Date ICMJE	September 11, 2000
First Posted Date ICMJE	January 27, 2003
Last Update Posted Date	February 11, 2013
Study Start Date ICMJE	November 2000
Actual Primary Completion Date	June 2005 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00006221 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	BMS-247550 in Treating Patients With Advanced Cancers
Official Title ICMJE	A Phase I Study of BMS-247550 (NSC 710428) Given Weekly X 3 Every 4 Weeks in Patients With Advanced Malignancies
Brief Summary	Phase I trial to study the effectiveness of BMS-247550 in treating patients who have malignant solid tumors or lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed Description	OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of BMS-247550 in patients with advanced malignancies. II. Determine the qualitative and quantitative toxic effects of this regimen in these patients. III. Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients. IV. Determine the antitumor effects of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients are stratified according to prior therapy (heavily pretreated vs minimally pretreated). Patients receive BMS-247550 IV over 1 hour once weekly on weeks 1-4. Courses repeat every 4 weeks 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 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level. Patients treated at the MTD receive treatment once weekly on weeks 1-3 of each 4-week course. Patients are followed within 1 month.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Lymphoma; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific
Intervention ICMJE	Drug: ixabepilone
Study Arms	Experimental: Arm I; Patients receive BMS-247550 IV over 1 hour once weekly on weeks 1-4. Courses repeat every 4 weeks 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 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level. Patients treated at the MTD receive treatment once weekly on weeks 1-3 of each 4-week course.; Intervention: Drug: ixabepilone
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 8, 2013)	54
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Actual Primary Completion Date	June 2005 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor or lymphoma for which no other potentially curative therapeutic option exists or demonstrates increased survival (considering tumor type, stage, and number of prior regimens); No symptomatic brain metastases requiring dexamethasone No progression or cerebral edema on CT scan or MRI within the past 4 weeks PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm^3; Hemoglobin at least 8.5 g/dL; Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No atrial or ventricular arrhythmias requiring medication; No ischemic event within the past 6 months Other: No pre-existing peripheral neuropathy greater than grade 1; No other serious medical illness or active infection that would preclude study participation; No dementia, psychiatric illness, or other alteration in mental status that would preclude study compliance; No other active malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix; No history of allergy or hypersensitivity reaction to paclitaxel or other Cremophor EL-containing compound; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 2 months after study completion PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered; No other concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior anticancer hormonal therapy and recovered; No concurrent hormonal therapy except LHRH agonists for non-castrated prostate cancer, contraceptives, hormone replacement therapy (e.g., conjugated estrogens), or megestrol as an appetite stimulant Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; Concurrent palliative radiotherapy to limited sites allowed Surgery: At least 4 weeks since prior surgery and recovered Other: At least 30 days since prior investigational agents and recovered; No other concurrent experimental medications; No concurrent antiretroviral (HAART) therapy for HIV-positive patients
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00006221
Other Study ID Numbers ICMJE	CDR0000068141; UTHSC-IDD-99-32; SACI-IDD-99-32; NCI-150
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	National Cancer Institute (NCI)
Study Sponsor ICMJE	National Cancer Institute (NCI)
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Chris H. Takimoto, MD, PhD, FACP The University of Texas Health Science Center at San Antonio
PRS Account	National Cancer Institute (NCI)
Verification Date	July 2004
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP