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Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00052754
Enrollment
48
Registered
2003-01-27
Start date
2002-10-31
Completion date
Unknown
Last updated
2012-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Keywords

adult synovial sarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

Brief 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.

Detailed description

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.

Interventions

DRUGgefitinib

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC
Lead SponsorNETWORK

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Progression-free rate at 12 weeks

Secondary

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

Countries

Belgium, France, Netherlands, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026