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Home > "G" Clinical Trials Conditions > Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma  Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
For Condition: stage 4B adult soft tissue sarcoma,stage 3 adult soft tissue sarcoma,stage 4A adult soft tissue sarcoma,recurrent adult soft tissue sarcoma,adult synovial sarcoma
Status: Recruiting
Sponsor(s): EORTC Soft Tissue and Bone Sarcoma Cooperative Group ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 1 prior combination chemotherapy regimen OR at least 1 but no more than 2 prior single-agent regimens - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Jean-YvesBlay, , Centre Leon Berard
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-10-439-1911
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-332-211
Cliniques Universitaires Saint-Luc *Recruiting*
Brussels, , 1200
Belgium
Recruiting Contact Person 32-2-764-1111
Leiden University Medical Center *Recruiting*
Leiden, , 2300 RC
Netherlands
Recruiting Contact Person 31-71-526-911
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital *Recruiting*
Amsterdam, , 1066 CX
Netherlands
Recruiting Contact Person 31-20-512-9111
Additional Information:
Study ID Numbers: CDR0000258735; EORTC-62022
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052754
Other Stage 3 Adult Soft Tissue Sarcoma Studies:
1. Radiation Therapy Plus Doxorubicin in Treating Patients With Resectable Primary or Recurrent Retroperitoneal Soft Tissue Sarcoma
2. Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer
3. Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
4. Chemotherapy, SU5416, Radiation Therapy, and Surgery in Treating Patients With Soft Tissue Sarcoma
5. Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma
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Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
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