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


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free rate at 12 weeks

Safety Issue:

No

Principal Investigator

Jean-Yves Blay, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Leon Berard

Authority:

United States: Federal Government

Study ID:

EORTC-62022

NCT ID:

NCT00052754

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Sarcoma
  • adult synovial sarcoma
  • stage III adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Sarcoma, Synovial
  • Sarcoma

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