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NCT00003557 Clinical Trial

Dolastatin 10 in Treating Patients With Metastatic Or Recurrent Liver, Bile Duct, or Gallbladder Cancer

Liver Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00003557
Other study ID # 9409
Secondary ID UCCRC-9409NCI-T9
Status Completed
Phase Phase 2
First received November 1, 1999
Last updated March 5, 2014
Start date January 1999
Est. completion date August 2003

Study information
Verified date March 2014
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date August 2003
Est. primary completion date June 2000
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• dolastatin 10

Locations
Country Name City State
United States Louis A. Weiss Memorial Hospital Chicago Illinois
United States University of Chicago Cancer Research Center Chicago Illinois
United States University of Illinois at Chicago Chicago Illinois
United States Cancer Care Specialists of Central Illinois, S.C. Decatur Illinois
United States Evanston Northwestern Health Care Evanston Illinois
United States Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne Indiana
United States University of Texas - MD Anderson Cancer Center Houston Texas
United States Lutheran General Cancer Care Center Park Ridge Illinois
United States Illinois Oncology Research Association Peoria Illinois
United States Michiana Hematology/Oncology P.C. South Bend Indiana
United States Central Illinois Hematology Oncology Center Springfield Illinois

Sponsors (2)
Lead Sponsor Collaborator
University of Chicago National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective Response Rate 2 years No
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