Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

This study has been completed.
Sponsor:
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
  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)
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014