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

Phase 2

Completed

• Conditions: Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer
• Interventions: Drug: dolastatin 10

• Registration Number: NCT00003557
• Lead Sponsor: University of Chicago

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1999-01
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-06
• Study Completion: 2003-08
• Study First Submitted QC: 2004-07-21
• Study First Posted: 2004-07-22
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-05
• Last Update Posted: 2014-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	dolastatin 10	Dolastatin-10 (400 mcg/m2 IV every 3 weeks)

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	2 years

Trial Locations

Locations (11)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Lutheran General Cancer Care Center; 🇺🇸 Park Ridge, Illinois, United States

Michiana Hematology/Oncology P.C.; 🇺🇸 South Bend, Indiana, United States

University of Chicago Cancer Research Center; 🇺🇸 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

Illinois Oncology Research Association; 🇺🇸 Peoria, Illinois, United States

Central Illinois Hematology Oncology Center; 🇺🇸 Springfield, Illinois, United States

Louis A. Weiss Memorial Hospital; 🇺🇸 Chicago, Illinois, United States