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Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
gefitinib
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring adult synovial sarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cliniques Universitaires Saint-Luc
  • U.Z. Gasthuisberg
  • Institut Bergonie
  • Centre Leon Berard
  • CHU de la Timone
  • Centre Antoine Lacassagne
  • Institut Curie - Section Medicale
  • Institut Gustave Roussy
  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
  • Leiden University Medical Center
  • Nijmegen Cancer Center at Radboud University Medical Center
  • Daniel Den Hoed Cancer Center at Erasmus Medical Center
  • Leeds Cancer Centre at St. James's University Hospital
  • Royal Marsden NHS Foundation Trust - London
  • Meyerstein Institute of Oncology at University College of London Hospitals
  • Christie Hospital N.H.S. Trust

Outcomes

Primary Outcome Measures

Progression-free rate at 12 weeks

Secondary Outcome Measures

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

Full Information

First Posted
January 24, 2003
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00052754
Brief Title
Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
Official Title
Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
adult synovial sarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gefitinib
Primary Outcome Measure Information:
Title
Progression-free rate at 12 weeks
Secondary Outcome Measure Information:
Title
Toxicity as assessed by CTC 2.0
Title
Response as assessed by RECIST criteria
Title
Time to onset of response
Title
Duration of response
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Yves Blay, MD, PhD
Organizational Affiliation
Centre Leon Berard
Official's Role
Study Chair
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Institut Curie - Section Medicale
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Nijmegen Cancer Center at Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Facility Name
Daniel Den Hoed Cancer Center at Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3008 AE
Country
Netherlands
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - London
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Meyerstein Institute of Oncology at University College of London Hospitals
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom
Facility Name
Christie Hospital N.H.S. Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18448563
Citation
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.
Results Reference
result

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Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

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