BMS-247550 in Treating Patients With Liver or Gallbladder Cancer

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Epothilone B; Epothilones

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