Clinical Trial: Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Study Trastuzumab (NSC 688097) in Her2/Neu Positive Cancer of the Gallbladder or Biliary Tract (NCI 7756)
Brief Summary: This phase II trial is studying how well trastuzumab works in treating patients with locally advanced or metastatic gallbladder cancer or bile duct cancer that cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them
Detailed Summary:
PRIMARY OBJECTIVE:
I. Determine the objective response rate and duration of objective response in patients with HER2/neu-positive advanced gallbladder or biliary tract cancer treated with trastuzumab (Herceptin).
SECONDARY OBJECTIVES:
I. Assess the safety and tolerability of this drug in these patients. II. Assess the progression-free survival and overall survival of patients treated with this drug.
OUTLINE:
Patients receive trastuzumab intravenously over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome: Objective Response (Complete and Partial Response) [ Time Frame: Baseline to 63 days or until disease progression ]
Original Primary Outcome: Objective response (complete and partial response)
Current Secondary Outcome:
- Disease Control Rate [ Time Frame: Up to 3.5 years ]Percentage of participants who have achieved complete response, partial response and stable disease
- Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: Up to 3 years ]Participant toxicity for study as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 reported in Results Adverse Event Reporting of record.
- Overall Survival [ Time Frame: Up to 3.5 years ]Length of time from date of starting treatment that participants are still alive
Original Secondary Outcome:
- Disease control rate
- Toxicity
- Overall survival
Information By: National Cancer Institute (NCI)
Dates:
Date Received: May 23, 2007
Date Started: May 2007
Date Completion:
Last Updated: May 15, 2014
Last Verified: September 2013