BMS-247550 in Treating Patients With Liver or Gallbladder Cancer

National Cancer Institute (NCI)

Status and phase: Terminated; Phase 2

Conditions: Recurrent Adult Primary Liver Cancer; Cholangiocarcinoma of the Extrahepatic Bile Duct; Recurrent Gallbladder Cancer; Localized Gallbladder Cancer; Unresectable Gallbladder Cancer; Unresectable Extrahepatic Bile Duct Cancer; Cholangiocarcinoma of the Gallbladder; Localized Unresectable Adult Primary Liver Cancer; Adult Primary Hepatocellular Carcinoma; Localized Resectable Adult Primary Liver Cancer; Advanced Adult Primary Liver Cancer; Recurrent Extrahepatic Bile Duct Cancer; Adult Primary Cholangiocellular Carcinoma; Localized Extrahepatic Bile Duct Cancer

Treatments: Other: laboratory biomarker analysis; Drug: ixabepilone

Study type: Interventional

Funder types: NIH

Identifiers

NCT00023946

CDR0000068878

NCI-3656

P30CA014599 (U.S. NIH Grant/Contract)

UCCRC-11045

UC#11045A (Other Identifier)

N01CM62201 (U.S. NIH Grant/Contract)

NCI-2012-02407 (Registry Identifier)

3656 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Treatment (ixabepilone)

Experimental group

Description:

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:

Drug: ixabepilone

Other: laboratory biomarker analysis