Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

Jean-Yves Blay

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00052754
Information obtained from ClinicalTrials.gov on December 20, 2011

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