Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00052754

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: gefitinib	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

48 participants

Masking:

None (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

Study Start Date :

Oct 1, 2002

Actual Primary Completion Date :

Oct 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques Universitaires Saint-Luc	Brussels		Belgium	1200
2	U.Z. Gasthuisberg	Leuven		Belgium	B-3000
3	Institut Bergonie	Bordeaux		France	33076
4	Centre Leon Berard	Lyon		France	69373
5	CHU de la Timone	Marseille		France	13385
6	Centre Antoine Lacassagne	Nice		France	06189
7	Institut Curie - Section Medicale	Paris		France	75248
8	Institut Gustave Roussy	Villejuif		France	F-94805
9	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital	Amsterdam		Netherlands	1066 CX
10	Leiden University Medical Center	Leiden		Netherlands	2300 RC
11	Nijmegen Cancer Center at Radboud University Medical Center	Nijmegen		Netherlands	NL-6500 HB
12	Daniel Den Hoed Cancer Center at Erasmus Medical Center	Rotterdam		Netherlands	3008 AE
13	Leeds Cancer Centre at St. James's University Hospital	Leeds	England	United Kingdom	LS9 7TF
14	Royal Marsden NHS Foundation Trust - London	London	England	United Kingdom	SW3 6JJ
15	Meyerstein Institute of Oncology at University College of London Hospitals	London	England	United Kingdom	WIT 3AA
16	Christie Hospital N.H.S. Trust	Manchester	England	United Kingdom	M20 4BX