Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma - Full Text View

Sponsored by:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00052754

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 II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: ZD1839

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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 ]

Study Start Date:

October 2002

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

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
Centre Antoine Lacassagne
Nice, France, 06189
Centre Leon Berard
Lyon, France, 69373
Institut Gustave Roussy
Villejuif, France, F-94805
Institut Bergonie
Bordeaux, France, 33076
Institut Curie - Section Medicale
Paris, France, 75248
CHU de la Timone
Marseille, France, 13385
Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, Netherlands, 3008 AE
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
Nijmegen Cancer Center at Radboud University Medical Center
Nijmegen, Netherlands, NL-6500 HB
United Kingdom, England
Royal Marsden NHS Foundation Trust - London
London, England, United Kingdom, SW3 6JJ
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
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 4BX

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Investigator:

Jean-Yves Blay, MD, PhD

Centre Leon Berard

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000258735, EORTC-62022
Study First Received:	January 24, 2003
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00052754 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult synovial sarcoma
stage III adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
stage IV adult soft tissue sarcoma

Study placed in the following topic categories:

Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Sarcoma

Synovial Sarcoma
Protein Kinase Inhibitors
Gefitinib
Recurrence

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Sarcoma, Synovial

Neoplasms, Connective and Soft Tissue
Neoplasms
Therapeutic Uses
Sarcoma
Neoplasms, Connective Tissue
Gefitinib

ClinicalTrials.gov processed this record on September 11, 2009