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 dolastatin 10 in treating patients with metastatic or recurrent liver, bile duct, or gallbladder cancer.

Condition	Treatment or Intervention	Phase
recurrent adult primary liver cancer advanced adult primary liver cancer cholangiocarcinoma of the gallbladder adult primary hepatocellular carcinoma recurrent gallbladder cancer unresectable gallbladder cancer recurrent extrahepatic bile duct cancer unresectable extrahepatic bile duct cancer	Drug: dolastatin 10	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the objective response rate, time to progression, and survival of patients with previously untreated advanced hepatobiliary cancer treated with dolastatin 10.

II. Determine the toxicity of this regimen in this patient population.

PROTOCOL OUTLINE: This is an open label, multicenter study.

Patients receive dolastatin 10 IV bolus every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed until death.

PROJECTED ACCRUAL: A total of 14-35 evaluable patients will be accrued for this study within 9 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed metastatic, locally advanced, or recurrent cancer of the liver (hepatoma), bile duct, or gallbladder (cholangiocarcinoma)
• Bidimensionally measurable disease; The following are not considered measurable lesions: Lesions seen on colonoscopic examination or barium studies; Bone metastases; CNS lesions CEA, CA19-9, or AFP levels; Ascites
• No CNS disease only
• No symptomatic brain metastases

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy for advanced or metastatic hepatobiliary cancer; No other concurrent chemotherapy; No concurrent investigational antineoplastic drugs
• Endocrine therapy: Not specified
• Radiotherapy: No prior radiotherapy to only site of measurable disease; At least 6 weeks since prior radiotherapy and recovered; No concurrent radiotherapy to any lesion
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: CALGB 0-2
• Life expectancy: Not specified
• Hematopoietic: WBC at least 3,500/mm3; Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 OR; Platelet count at least 75,000/mm3 in patients with clinically documented sequestration or hemodilution unrelated to primary bone marrow insufficiency; Hemoglobin at least 9.0 g/dL
• Hepatic: Bilirubin no greater than 1.5 mg/dL; Transaminases no greater than 5 times upper limit of normal
• Renal: Creatinine no greater than 1.5 mg/dL OR; Creatinine clearance at least 60 mL/min
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No significant underlying medical or psychiatric illness; No active infections; No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer and carcinoma in situ of the cervix

Illinois
      Cancer Care Specialists of Central Illinois, S.C., Decatur,  Illinois,  62526,  United States
      Central Illinois Hematology Oncology Center, Springfield,  Illinois,  62701,  United States
      Evanston Northwestern Health Care, Evanston,  Illinois,  60201,  United States
      Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
      Louis A. Weiss Memorial Hospital, Chicago,  Illinois,  60640,  United States
      Lutheran General Cancer Care Center, Park Ridge,  Illinois,  60068,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States
      University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States
Indiana
      Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne,  Indiana,  46885-5099,  United States
      Michiana Hematology/Oncology P.C., South Bend,  Indiana,  46617,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Hedy L. Kindler,  Study Chair,  University of Chicago Cancer Research Center   

Study ID Numbers:  CDR0000066620; UCCRC-9409; NCI-T98-0010
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003557
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08