Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

BMS-247550 in Treating Patients With Advanced Cancers

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI UTHSC-IDD-99-32 SACI-IDD-99-32, NCI-150, NCT00006221, 150

Objectives

1. Determine the maximum tolerated dose and recommended phase II dose of BMS-247550 in patients with advanced malignancies.
2. Determine the qualitative and quantitative toxic effects of this regimen in these patients.
3. Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
4. Determine the antitumor effects of this regimen in these patients.

Entry Criteria

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

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:

• 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Neutrophil count at least 1,500/mm³
• Hemoglobin at least 8.5 g/dL
• Platelet count at least 100,000/mm³

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

Expected Enrollment

Approximately 54 patients will be accrued for this study within 1 year.

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.

Trial Contact Information

Trial Lead Organizations

University of Texas Health Science Center at San Antonio

Chris Takimoto, MD, PhD, FACP, Protocol chair		Ph: 210-562-1725

Registry Information
Official Title		A Phase I Study of BMS-247550 (NSC 710428) Given Weekly X 3 Every 4 Weeks in Patients with Advanced Malignancies
Trial Start Date		2000-11-14
Registered in ClinicalTrials.gov		NCT00006221
Date Submitted to PDQ		2000-07-06
Information Last Verified		2004-07-19
NCI Grant/Contract Number		U01-CA69853

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