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A Phase II Trial Of The Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Hepatobiliary Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Adult Primary Cholangiocellular Carcinoma, Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Localized Extrahepatic Bile Duct Cancer, Localized Gallbladder Cancer, Localized Resectable Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer

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Trial Information

A Phase II Trial Of The Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Hepatobiliary Cancer


PRIMARY OBJECTIVES:

I. Determine the objective response rate of patients with hepatobiliary cancer treated with
BMS-247550.

II. Determine the toxicity of this drug in these patients. III. Determine the duration of
response, median and overall survival, and time to progression in patients treated with this
drug.

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


Inclusion Criteria:



- 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

- Performance status - ECOG 0-2

- At least 3 months

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin no greater than 1.5 mg/dL

- AST/ALT no greater than 2.5 times upper limit of normal

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- 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

- No concurrent immunotherapy

- No prior chemotherapy

- No other concurrent chemotherapy

- No concurrent hormonal therapy

- No concurrent therapeutic radiotherapy

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (partial or complete response) evaluated by RECIST

Outcome Description:

A 10% response rate precludes further study whereas a 25% response rate would indicate that further study is warranted.

Outcome Time Frame:

Up to 8 years

Safety Issue:

No

Principal Investigator

Hedy Kindler

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02407

NCT ID:

NCT00023946

Start Date:

August 2001

Completion Date:

Related Keywords:

  • Adult Primary Cholangiocellular Carcinoma
  • Adult Primary Hepatocellular Carcinoma
  • Advanced Adult Primary Liver Cancer
  • Cholangiocarcinoma of the Extrahepatic Bile Duct
  • Cholangiocarcinoma of the Gallbladder
  • Localized Extrahepatic Bile Duct Cancer
  • Localized Gallbladder Cancer
  • Localized Resectable Adult Primary Liver Cancer
  • Localized Unresectable Adult Primary Liver Cancer
  • Recurrent Adult Primary Liver Cancer
  • Recurrent Extrahepatic Bile Duct Cancer
  • Recurrent Gallbladder Cancer
  • Unresectable Extrahepatic Bile Duct Cancer
  • Unresectable Gallbladder Cancer
  • Carcinoma
  • Liver Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Cholangiocarcinoma
  • Carcinoma, Hepatocellular

Name

Location
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470