Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery

Phase 2

Terminated

• Conditions: Adenocarcinoma of the Extrahepatic Bile Duct; Recurrent Extrahepatic Bile Duct Cancer; Unresectable Gallbladder Cancer; Adenocarcinoma of the Gallbladder; Malignant Neoplasm; Unresectable Extrahepatic Bile Duct Cancer; Recurrent Gallbladder Cancer
• Interventions: Biological: trastuzumab; Other: laboratory biomarker analysis

• Registration Number: NCT00478140
• Lead Sponsor: National Cancer Institute (NCI)

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 Description

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-23
• Study First Submitted QC: 2007-05-23
• Study First Posted: 2007-05-24
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2013-09-17
• Results First Submitted QC: 2013-09-17
• Results First Posted: 2013-11-19
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trastuzumab	trastuzumab	Participants receive trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Trastuzumab	laboratory biomarker analysis	Participants receive trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Objective Response (Complete and Partial Response)	Baseline to 63 days or until disease progression	Response assessed using imaging-based evaluation at baseline then following single agent trastuzumab administered over 21 day cycle, re-staging done following 2 cycles. Response Evaluation Criteria in Solid Tumors defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate	Up to 3.5 years	Percentage of participants who have achieved complete response, partial response and stable disease
Overall Survival	Up to 3.5 years	Length of time from date of starting treatment that participants are still alive
Number of Participant With Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	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.

Trial Locations

Locations (2)

University of Southern California, Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

The University of Texas (UT) MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States