Clinical trial · Interventional
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
NCT00052754CI-TRIAL-00008091completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free rate at 12 weeks
Secondary outcomes (5)
- measure
- Toxicity as assessed by CTC 2.0
- measure
- Response as assessed by RECIST criteria
- measure
- Time to onset of response
- measure
- Duration of response
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTRay-Coquard I, Le Cesne A, Whelan JS, Schoffski P, Bui BN, Verweij J, Marreaud S, van Glabbeke M, Hogendoorn P, Blay JY. A phase II study of gefitinib for patients with advanced HER-1 expressing synovial sarcoma refractory to doxorubicin-containing regimens. Oncologist. 2008 Apr;13(4):467-73. doi: 10.1634/theoncologist.2008-0065. PMID 18448563