Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	EORTC-62022 NCT00052754

Objectives

1. Determine the therapeutic activity of gefitinib, in terms of progression-free rate, in patients with locally advanced or metastatic synovial sarcoma expressing HER1.
2. Determine the toxicity of this drug in these patients.
3. Determine the objective response, in terms of time to onset and duration of response, in patients treated with this drug.
4. Determine the overall survival of patients treated with this drug.

Entry Criteria

Disease Characteristics:

• Histologically proven advanced or metastatic synovial sarcoma that is not amenable to surgery, radiotherapy, or combined modality treatment with curative intent



• HER1 antigen expression



• Must have received at least 1 prior chemotherapy regimen comprising doxorubicin and/or ifosfamide



• At least 1 measurable lesion with evidence of progression within 3 months of study
  • Osseous lesions and pleural effusions are not considered measurable



• No symptomatic or known CNS metastases

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• At least 28 days since prior chemotherapy and recovered

Endocrine therapy

• Not specified

Radiotherapy

• At least 3 months since prior radiotherapy to measurable lesion and recovered
• No concurrent radiotherapy for soft tissue sarcoma
• Concurrent palliative radiotherapy to nontarget lesions allowed

Surgery

• Not specified

Other

• More than 28 days since prior unapproved or investigational drugs and recovered
• No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's Wort)
• No other concurrent cytostatic agents
• No other concurrent tyrosine kinase activity inhibitors
• No other concurrent systemic therapy for soft tissue sarcoma

Patient Characteristics:

Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC greater than 3,000/mm³
• Granulocyte count greater than 1,000/mm³
• Platelet count greater than 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• Albumin at least 25 g/L

Renal

• Creatinine no greater than 2 times ULN

  OR

• Creatinine clearance greater than 65 mL/min

Cardiovascular

• No history of severe cardiovascular disease

Pulmonary

• No evidence of clinically active interstitial lung disease
  • Asymptomatic chronic stable radiographic changes allowed

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No known severe hypersensitivity to gefitinib or any of its excipients
• No other primary malignant tumor except adequately treated carcinoma in situ of the cervix, basal cell skin cancer, or any other malignant tumor in complete remission for at least 3 years
• No other severe medical illness
• No psychosis
• No psychological, familial, sociological, or geographical condition that would preclude study compliance

Expected Enrollment

A total of 14-44 patients will be accrued for this study within 18 months.

Outcomes

Progression-free rate at 12 weeks

Toxicity as assessed by CTC 2.0
Response as assessed by RECIST criteria
Time to onset of response
Duration of response
Overall survival

Outline

This is a non-randomized, multicenter study.

Patients receive oral gefitinib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

Ray-Coquard I, Le Cesne A, Whelan JS, et al.: A phase II study of gefitinib for patients with advanced HER-1 expressing synovial sarcoma refractory to doxorubicin-containing regimens. Oncologist 13 (4): 467-73, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Jean-Yves Blay, MD, PhD, Study coordinator		Ph: 33-78-782-828 Email: blay@lyon.fnclcc.fr

Registry Information
Official Title		Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1
Trial Start Date		2002-10-28
Registered in ClinicalTrials.gov		NCT00052754
Date Submitted to PDQ		2002-10-29
Information Last Verified		2006-01-05

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