Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
This study has been completed.
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00052754
First received: January 24, 2003
Last updated: September 20, 2012
Last verified: September 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: gefitinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1 |
Resource links provided by NLM:
Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:
Primary Outcome Measures:
- Progression-free rate at 12 weeks [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity as assessed by CTC 2.0 [ Designated as safety issue: Yes ]
- Response as assessed by RECIST criteria [ Designated as safety issue: No ]
- Time to onset of response [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Enrollment: | 48 |
| Study Start Date: | October 2002 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052754
Locations
| Belgium | |
| Cliniques Universitaires Saint-Luc | |
| Brussels, Belgium, 1200 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| France | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Centre Leon Berard | |
| Lyon, France, 69373 | |
| CHU de la Timone | |
| Marseille, France, 13385 | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| Institut Curie - Section Medicale | |
| Paris, France, 75248 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Netherlands | |
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | |
| Amsterdam, Netherlands, 1066 CX | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 RC | |
| Nijmegen Cancer Center at Radboud University Medical Center | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
| Rotterdam, Netherlands, 3008 AE | |
| United Kingdom | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Meyerstein Institute of Oncology at University College of London Hospitals | |
| London, England, United Kingdom, WIT 3AA | |
| Royal Marsden NHS Foundation Trust - London | |
| London, England, United Kingdom, SW3 6JJ | |
| Christie Hospital N.H.S. Trust | |
| Manchester, England, United Kingdom, M20 4BX | |
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Study Chair: | Jean-Yves Blay, MD, PhD | Centre Leon Berard |
More Information
Additional Information:
Publications:
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00052754 History of Changes |
| Other Study ID Numbers: | EORTC-62022, EORTC-62022 |
| Study First Received: | January 24, 2003 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
adult synovial sarcoma stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage IV adult soft tissue sarcoma |
Additional relevant MeSH terms:
|
Sarcoma, Synovial Sarcoma Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Gefitinib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013