BMS-247550 in Treating Patients With Advanced Cancers - Article
Clinical Trial: BMS-247550 in Treating Patients With Advanced Cancers
This study is currently recruiting patients.
|Condition||Treatment or Intervention||Phase|
|adult solid tumor |
small intestine cancer
| Drug: ixabepilone |
|Phase I |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Digestive Diseases; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of BMS-247550 in Patients With Advanced Malignancies
- Determine the maximum tolerated dose and recommended phase II dose of BMS-247550 in patients with advanced malignancies.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
- 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).
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.
PROJECTED ACCRUAL: Approximately 54 patients will be accrued for this study within 1 year.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- 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
- ECOG 0-2
- At least 12 weeks
- Neutrophil count at least 1,500/mm^3
- Hemoglobin at least 8.5 g/dL
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- Creatinine no greater than 1.5 mg/dL
- No atrial or ventricular arrhythmias requiring medication
- No ischemic event within the past 6 months
- 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
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
- No other concurrent chemotherapy
- See Disease Characteristics
- 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
- At least 4 weeks since prior radiotherapy and recovered
- Concurrent palliative radiotherapy to limited sites allowed
- At least 4 weeks since prior surgery and recovered
- At least 30 days since prior investigational agents and recovered
- No other concurrent experimental medications
- No concurrent antiretroviral (HAART) therapy for HIV-positive patients
Location and Contact Information
Cancer Therapy and Research Center, San Antonio, Texas, 78229, United States; Recruiting
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78284-7811, United States; Recruiting
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, 78229, United States; Recruiting
Record last reviewed: June 2004
Last Updated: December 6, 2004
Record first received: September 11, 2000
ClinicalTrials.gov Identifier: NCT00006221
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005