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CompletedNCT00104949Updated Jun 24, 2013

Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

A Phase 2 interventional study of trastuzumab in Sarcoma, sponsored by SWOG Cancer Research Network. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-24.

Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sarcoma

Keywords

  • adult synovial sarcoma
  • recurrent adult soft tissue sarcoma
  • stage III adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 1,283 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed synovial sarcoma meeting 1 of the following stage criteria:

    • Locally advanced disease, defined as 1 of the following:

      • Incurable by conventional multidisciplinary therapy, including surgery
      • Surgically resectable only with significant morbidity
    • Metastatic disease
  • Tumor HER2/neu positive (2+ or 3+) by immunohistochemistry
  • Tumor tissue must be available AND patient must be willing to allow specimen submission
  • Measurable disease
  • No known CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,000/mm\^3
  • Hemoglobin > 8 g/dL
  • Platelet count > 100,000/mm\^3

Hepatic

  • Bilirubin \< 1.5 times upper limit of normal (ULN)
  • SGOT and/or SGPT \< 1.5 times ULN (5 times ULN if liver metastases are present)

Renal

  • Creatinine \< 1.5 times ULN OR
  • Creatinine clearance > 60 mL/min

Cardiovascular

  • LVEF > 45% by MUGA

Gastrointestinal

  • No active peptic ulcer disease
  • No active gastrointestinal bleeding
  • No active inflammatory bowel disease

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No known HIV positivity
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent filgrastim (G-CSF)

Chemotherapy

  • At least 3 weeks since prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 60 days since prior radiotherapy to the target lesion*
  • No concurrent radiotherapy NOTE: *Lesion must have demonstrated disease progression after completion of therapy

Surgery

  • At least 21 days since prior major surgery and recovered

Other

  • At least 60 days since prior embolization or radiofrequency ablation to the target lesion* NOTE: *Lesion must have demonstrated disease progression after completion of therapy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Enrollment
40 participants (estimated)

Interventions

  • Biologicaltrastuzumab
06

What researchers measure

Primary outcomes

  1. Response rate (confirmed complete response and partial response)

Secondary outcomes

  1. Progression-free survival at 1 and 2 years

  2. Overall survival at 1 and 2 years

  3. Toxicity

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00104949
Lead sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
First posted
Mar 4, 2005
Start date
Jul 2005
Completion
Aug 2007
Last update
Jun 24, 2013

Study contacts

Ernest C. Borden, MD
The Cleveland Clinic
Rashmi Chugh, MD
University of Michigan Rogel Cancer Center
George D. Demetri, MD
Dana-Farber Cancer Institute
Margaret von Mehren, MD
Fox Chase Cancer Center
Vivien H.C. Bramwell, MB, BS, PhD, FRCP
Tom Baker Cancer Centre - Calgary
Karen H. Albritton, MD
Dana-Farber Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

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