NCT00052754

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
4 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

3 years

First QC Date

January 24, 2003

Last Update Submit

September 20, 2012

Conditions

Sarcoma

Keywords

adult synovial sarcomastage III adult soft tissue sarcomarecurrent adult soft tissue sarcomastage IV adult soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

gefitinibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (16)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie - Section Medicale

Paris, 75248, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Nijmegen Cancer Center at Radboud University Medical Center

Nijmegen, NL-6500 HB, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Royal Marsden NHS Foundation Trust - London

London, England, SW3 6JJ, United Kingdom

Location

Meyerstein Institute of Oncology at University College of London Hospitals

London, England, WIT 3AA, United Kingdom

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 18448563RESULT

MeSH Terms

Conditions

SarcomaSarcoma, Synovial

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Connective Tissue

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jean-Yves Blay, MD, PhD

    Centre Leon Berard

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

October 1, 2002

Primary Completion

October 1, 2005

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

GB(4)BE(2)NL(4)FR(6)