RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of synovial sarcoma.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic synovial sarcoma.

Condition	Treatment or Intervention	Phase
adult synovial sarcoma stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage IV adult soft tissue sarcoma	Drug: gefitinib  Procedure: enzyme inhibitor therapy  Procedure: protein tyrosine kinase inhibitor therapy	Phase II

Further Study Details: 

OBJECTIVES:

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

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.

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

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

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

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

Belgium
      Cliniques Universitaires Saint-Luc, Brussels,  1200,  Belgium; Recruiting
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium; Recruiting
France
      Centre Antoine Lacassagne, Nice,  06189,  France; Recruiting
      Centre Leon Berard, Lyon,  69373,  France; Recruiting
      CHU de la Timone, Marseille,  13385,  France; Recruiting
      Institut Bergonie, Bordeaux,  33076,  France; Recruiting
      Institut Curie - Section Medicale, Paris,  75248,  France; Recruiting
      Institut Gustave Roussy, Villejuif,  F-94805,  France; Recruiting
Netherlands
      Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam,  3008 AE,  Netherlands; Recruiting
      Leiden University Medical Center, Leiden,  2300 RC,  Netherlands; Recruiting
      Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam,  1066 CX,  Netherlands; Recruiting
      University Medical Center Nijmegen, Nijmegen,  NL-6500 HB,  Netherlands; Recruiting
United Kingdom, England
      Christie Hospital N.H.S. Trust, Manchester,  England,  M20 4BX,  United Kingdom; Recruiting
      Meyerstein Institute of Oncology at University College of London Hospitals, London,  England,  WIT 3AA,  United Kingdom; Recruiting
      Royal Marsden NHS FoundationTrust - London, London,  England,  SW3 6JJ,  United Kingdom; Recruiting
      St. James's University Hospital at Leeds Teaching Hospital NHS Trust, Leeds,  England,  LS9 7TF,  United Kingdom; Recruiting

Study chairs or principal investigators

Jean-Yves Blay, MD, PhD,  Centre Leon Berard   

Study ID Numbers:  CDR0000258735; EORTC-62022; NCT00052754
Record last reviewed:  March 2005
Last Updated:  March 15, 2005
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052754
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08