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AzTrials

SarcomaPhase 2NCT00104949

Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

A Phase 2 study testing trastuzumab in people with Sarcoma, run by SWOG Cancer Research Network.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
What is being tested?
trastuzumab
How many people
40 participants
Where
No sites listed yet
Study dates
Jul 2005to Aug 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

About this study

Official title: Phase II Study of Trastuzumab (NSC-688097) in Treatment of Locally Advanced or Metastatic Synovial Sarcoma

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.

Conditions
Sarcoma
Being tested
trastuzumab
Keywords
adult synovial sarcoma, recurrent adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
Medical subject headings
Sarcoma, Sarcoma, Synovial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

  1. Progression-free survival at 1 and 2 years

  2. Overall survival at 1 and 2 years

  3. Toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2005 (estimated)
  2. Study startJul 2005
  3. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00104949
Sponsor's protocol ID
CDR0000413703
Other IDs
SWOG-S0346
Status last verified
Dec 2006
First submitted
3 Mar 2005
Last updated
24 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing trastuzumab in people with Sarcoma, run by SWOG Cancer Research Network.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (confirmed complete response and partial response). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00104949.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.

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