BMS-247550 in Treating Patients With Liver or Gallbladder Cancer

Phase 2

Terminated

• Conditions: 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
• Interventions: Drug: ixabepilone; Other: laboratory biomarker analysis

• Registration Number: NCT00023946
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Phase II trial to study the effectiveness of BMS-247550 in treating patients who have liver or gallbladder cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed Description

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

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2001-09-13
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-07
• Study Completion: 2009-11
• Status Verified: 2012-12
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (ixabepilone)	laboratory biomarker analysis	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.
Treatment (ixabepilone)	ixabepilone	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.

Primary Outcome Measures

Name	Time	Method
Objective response rate (partial or complete response) evaluated by RECIST	Up to 8 years	A 10% response rate precludes further study whereas a 25% response rate would indicate that further study is warranted.
Frequency and extent of cytotoxic activity graded according to the NCI CTC Version 2.0	Up to 8 years
Time to disease progression	From the first day of treatment until the date PD or death is first reported, assessed up to 8 years	Will also be evaluated using the Kaplan-Meier estimator.
Overall survival	From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that PD is objectively documented, assessed up to 10 years	Will also be evaluated using the Kaplan-Meier estimator.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States