Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

Sarcoma Clinical Trial

Official title:

Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00052754
• Other study ID #: EORTC-62022
• Secondary ID: EORTC-62022
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2003
• Last updated: September 20, 2012
• Start date: October 2002

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Synovial

Intervention

Drug:
• gefitinib

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	U.Z. Gasthuisberg	Leuven
France	Institut Bergonie	Bordeaux
France	Centre Leon Berard	Lyon
France	CHU de la Timone	Marseille
France	Centre Antoine Lacassagne	Nice
France	Institut Curie - Section Medicale	Paris
France	Institut Gustave Roussy	Villejuif
Netherlands	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital	Amsterdam
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Nijmegen Cancer Center at Radboud University Medical Center	Nijmegen
Netherlands	Daniel Den Hoed Cancer Center at Erasmus Medical Center	Rotterdam
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Meyerstein Institute of Oncology at University College of London Hospitals	London	England
United Kingdom	Royal Marsden NHS Foundation Trust - London	London	England
United Kingdom	Christie Hospital N.H.S. Trust	Manchester	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Netherlands,  United Kingdom, 

References & 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 regime — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free rate at 12 weeks			No
Secondary	Toxicity as assessed by CTC 2.0			Yes
Secondary	Response as assessed by RECIST criteria			No
Secondary	Time to onset of response			No
Secondary	Duration of response			No
Secondary	Overall survival			No