Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

Phase 2

Completed

• Conditions: Sarcoma

• Registration Number: NCT00104949
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

RATIONALE: 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. Trastuzumab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well trastuzumab works in treating patients with locally advanced or metastatic synovial sarcoma.

Detailed Description

OBJECTIVES:

Primary

* Determine the response rate (confirmed complete response and partial response) in patients with HER2/neu-overexpressing locally advanced or metastatic synovial sarcoma treated with trastuzumab (Herceptin\^®).

Secondary

* Determine the frequency and severity of toxic effects of this drug in these patients.

* Determine overall survival and progression-free survival of patients treated with this drug.

* Correlate, preliminarily, SYT-SSX translocation, HER2/neu expression, and monophasic and biphasic phenotype with clinical outcomes in patients treated with this drug.

OUTLINE: This is a pilot, multicenter study.

Patients receive trastuzumab (Herceptin\^®) IV over 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 6 weeks until disease progression and then every 6 months for up to 2 years from study entry.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10-40 months.

Study Timeline

• Study First Submitted: 2005-03-03
• Study First Submitted QC: 2005-03-03
• Study First Posted: 2005-03-04
• Study Start: 2005-07
• Status Verified: 2006-12
• Study Completion: 2007-08
• Last Update Submitted: 2013-06-21
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate (confirmed complete response and partial response)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival at 1 and 2 years
Overall survival at 1 and 2 years
Toxicity