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

Alternate Title

BMS-247550 in Treating Patients With Liver or Gallbladder Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI UCCRC-11045 NCI-3656, 3656, NCT00023946

Objectives

1. Determine the objective response rate of patients with hepatobiliary cancer treated with BMS-247550.
2. Determine the toxicity of this drug in these patients.
3. Determine the duration of response, median and overall survival, and time to progression in patients treated with this drug.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed locally advanced, metastatic, or recurrent hepatobiliary cancer
  • Liver (hepatocellular)
  • Bile duct (cholangiocarcinoma)
  • Gallbladder



• At least 1 unidimensionally measurable lesion
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • The following are not considered measurable lesions:
    • Lesions seen on colonoscopic examination or barium studies
    • Bone metastases
    • CNS lesions
    • Ascites



• No brain metastases

Prior/Concurrent Therapy:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy

Radiotherapy:

• No concurrent therapeutic radiotherapy

Surgery:

• Not specified

Other:

• At least 30 days since prior investigational agents
• At least 7 days since prior cimetidine
• No concurrent cimetidine
• No other concurrent commercial or investigational anticancer agents or therapies
• No concurrent unconventional therapies, food, or vitamin supplements (e.g., St. John's Wort)
• No concurrent combination antiretroviral therapy for HIV-positive patients

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• AST/ALT no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL

  OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other:

• No grade 2 or greater peripheral neuropathy
• No other uncontrolled concurrent illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No prior allergic hypersensitivity reaction attributed to compounds containing Cremophor EL (e.g., paclitaxel or compounds of similar chemical or biological composition to BMS-247550)
• No other currently active malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer for which patient has completed therapy and is at less than 30% risk of relapse
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 21-50 patients will be accrued for this study within 14 months.

Outline

This is a multicenter study.

Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks until disease progression.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Hedy Kindler, MD, Protocol chair		Ph: 773-702-0360; 888-824-0200

Registry Information
Official Title		A Phase II Trial Of The Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Hepatobiliary Cancer
Trial Start Date		2001-10-05
Registered in ClinicalTrials.gov		NCT00023946
Date Submitted to PDQ		2001-07-11
Information Last Verified		2005-06-02
NCI Grant/Contract Number		CA17102, CA14599, CA63187

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