SarcomaPhase 2NCT00052754
Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
A Phase 2 study testing gefitinib in people with Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 16 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- gefitinib
- How many people
- 48 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Oct 2002to Oct 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
France6 sites
Institut Bergonie
Bordeaux, 33076
Centre Leon Berard
Lyon, 69373
CHU de la Timone
Marseille, 13385
Centre Antoine Lacassagne
Nice, 06189
Institut Curie - Section Medicale
Paris, 75248
Institut Gustave Roussy
Villejuif, F-94805
Netherlands4 sites
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, 1066 CX
Leiden University Medical Center
Leiden, 2300 RC
Nijmegen Cancer Center at Radboud University Medical Center
Nijmegen, NL-6500 HB
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, 3008 AE
United Kingdom4 sites
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Royal Marsden NHS Foundation Trust - London
London, England, SW3 6JJ
Meyerstein Institute of Oncology at University College of London Hospitals
London, England, WIT 3AA
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
Belgium2 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
U.Z. Gasthuisberg
Leuven, B-3000
About this study
Official title: Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gefitinibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free rate at 12 weeks
Secondary outcomes (5)
Toxicity as assessed by CTC 2.0
Response as assessed by RECIST criteria
Time to onset of response
Duration of response
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2002
- Primary completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jean-Yves Blay, MD, PhD, Study chair, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052754
- Sponsor's protocol ID
- EORTC-62022
- Other IDs
- EORTC-62022
- Status last verified
- Sep 2012
- First submitted
- 24 Jan 2003
- Last updated
- 24 Sep 2012
- Results posted
- No
Publications
Ray-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.
PubMed 18448563
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1
- ClinicalTrials.gov ID
- NCT00052754
- Acronym / sponsor ID
- EORTC-62022
- Conditions
- Sarcoma
- Keywords
- adult synovial sarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Oct 2002
- Primary completion
- Oct 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gefitinib | Drug | – |
Primary outcome
Progression-free rate at 12 weeks
5 secondary outcomes
Toxicity as assessed by CTC 2.0
Response as assessed by RECIST criteria
Time to onset of response
Duration of response
Overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
- Results publication: PubMed 18448563Ray-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Yves Blay, MD, PhD study chair
Centre Leon Berard
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gefitinib in people with Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 16 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France, Netherlands, United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free rate at 12 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00052754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.