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BMS-247550 in Treating Patients With Liver or Gallbladder Cancer



BMS-247550 in Treating Patients With Liver or Gallbladder Cancer

For Condition: Gallbladder Cancer,extrahepatic bile duct cancer,adult primary liver cancer
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have liver or gallbladder cancer.
Details: OBJECTIVES: - Determine the objective response rate of patients with hepatobiliary cancer treated with BMS-247550. - Determine the toxicity of this drug in these patients. - 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. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 14 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
HedyKindler,  Study Chair,  University of Chicago Cancer Research Center

LaGrange Memorial Hospital *Recruiting*
LaGrange,  Illinois,  60525
United States
Recruiting James  Hannigan 708-579-3418

Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston,  Illinois,  60201-1781
United States
Recruiting Gregory  Masters 847-570-2515

University of Illinois Medical Center *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Michael  Mullane 312-996-7975

Lutheran General Cancer Care Center *Recruiting*
Park Ridge,  Illinois,  60068
United States
Recruiting Brian  Samuels 847-268-8200

Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood,  Illinois,  60153
United States
Recruiting Ellen  Gaynor 708-327-3101

USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles,  California,  90033
United States
Recruiting Heinz-Josef  Lenz 323-865-3955

Decatur Memorial Hospital Cancer Care Institute *Recruiting*
Decatur,  Illinois,  62526
United States
Recruiting James  Wade 217-876-6603

Central Illinois Hematology Oncology Center *Recruiting*
Springfield,  Illinois,  62701
United States
Recruiting Edem  Agamah 217-525-2500

Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne,  Indiana,  46885-5099
United States
Recruiting David  Sciortino 219-484-8830

Michiana Hematology-Oncology, P.C. - South Bend *Recruiting*
South Bend,  Indiana,  46617
United States
Recruiting David  Taber 219-237-1328

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60637-1470
United States
Recruiting Hedy  Kindler 773-702-0360

Oncology/Hematology Associates of Central Illinois, P.C. *Recruiting*
Peoria,  Illinois,  61602
United States
Recruiting James  Knost 309-672-5681


Additional Information:
Study ID Numbers:
  CDR0000068878;  UCCRC-11045,NCI-3656
Study Start Date: 
Record last reviewed: March 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023946

Other Gallbladder Cancer Studies:
1. BMS-247550 in Treating Patients With Liver or Gallbladder Cancer

2. Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma

3. Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer

4. Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas

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