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A Phase II Trial of Dolastatin-10 (NSC 376128) Administered as an IV Bolus Every 3 Weeks in Patients With Hepatobiliary Cancer

Phase 2
18 Years
Not Enrolling
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer

Thank you

Trial Information

A Phase II Trial of Dolastatin-10 (NSC 376128) Administered as an IV Bolus Every 3 Weeks in Patients With Hepatobiliary Cancer

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.

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.

Inclusion 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

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

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Hedy L. Kindler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

January 1999

Completion Date:

August 2003

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • unresectable extrahepatic bile duct cancer
  • recurrent extrahepatic bile duct cancer
  • adult primary hepatocellular carcinoma
  • cholangiocarcinoma of the gallbladder
  • Liver Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Chicago Cancer Research Center Chicago, Illinois  60637
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
Evanston Northwestern Health Care Evanston, Illinois  60201
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
University of Illinois at Chicago Chicago, Illinois  60612
Cancer Care Specialists of Central Illinois, S.C. Decatur, Illinois  62526
Central Illinois Hematology Oncology Center Springfield, Illinois  62701
Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne, Indiana  46885-5099
Michiana Hematology/Oncology P.C. South Bend, Indiana  46617
Illinois Oncology Research Association Peoria, Illinois  61602