Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Leflunomide in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over Pharmaceutical / Industry SUGEN-SU101.010

Objectives

I.  Assess the objective response, one year and overall survival, and time to 
progression in patients with advanced non-small cell lung cancer treated with 
intravenous leflunomide (SU101).

II.  Assess the relationship between activity and the expression of 
platelet-derived growth factor receptors (via immunohistochemistry) in 
archived non-small cell lung tumor tissue samples.

III.  Assess the safety of SU101 in these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed stage IIIB or stage IV non-small cell lung cancer

Must have received maximally feasible surgical resection and/or radiotherapy
for initial disease

Must have received one prior chemotherapy regimen with cisplatin/paclitaxel,
carboplatin/paclitaxel, or cisplatin/vinorelbine at a standard dose and
schedule
 Must have achieved an objective response on this regimen
 Must have sustained response as observed on the assessment at the time of
  screening
 Last dose must have been administered within 3-6 weeks prior to initiating
  study drug treatment

Must have bidimensionally measurable disease by MRI, CT, or radiography
(unless the patient has had a complete response)
 At least one lesion must be at least 2 cm in one dimension 
 Any lesion that has received radiotherapy is not to be followed for response

No known CNS metastases

Prior/Concurrent Therapy:

Biologic therapy:
 No concurrent immunotherapy

Chemotherapy:
 See Disease Characteristics
 No prior leflunomide (SU101)
 No other concurrent chemotherapy

Endocrine therapy:
 No concurrent hormonal therapy for non-small cell lung cancer

Radiotherapy:
 See Disease Characteristics
 At least 2 weeks since prior radiotherapy
 No concurrent radiotherapy to lesions followed for response

Surgery:
 See Disease Characteristics
 At least 2 weeks since surgery
 No concurrent surgery for non-small cell lung cancer

Other:
 No concurrent cholestyramine
 No other concurrent investigational agents

Patient Characteristics:

Age:
 18 and over

Performance status:
 Karnofsky 70-100%

Life expectancy:
 Not specified

Hematopoietic:
 Absolute neutrophil count at least 1,000/mm3
 Platelet count at least 75,000/mm3
 Hemoglobin at least 8 g/dL
  Stable hemoglobin must be maintained without blood transfusion(s) within 2
   weeks prior to study (use of hematopoietic growth factors is allowed)

Hepatic:
 Bilirubin less than 1.5 times upper limit of normal (ULN)
 AST/ALT no greater than 2.5 times ULN

Renal:
 Creatinine no greater than 2.2 mg/dL

Other:
 No known allergy to etoposide
 No body weight loss of 10% or greater during the prior 3 months
 No other acute or chronic medical or psychiatric condition, or a laboratory
  abnormality that may increase the risks associated with study
  participation/study drug administration or may interfere with the
  interpretation of study results
 No history of another malignancy in the last 5 years other than carcinoma in
  situ of the cervix or basal cell carcinoma of the skin 
 Not pregnant 
 Negative pregnancy test within 7 days prior to study
 Adequate contraception is required for all fertile patients

Expected Enrollment

There will be 15-30 patients accrued into this study. 

Outline

This is an open label, multicenter study.

Patients receive leflunomide (SU101) IV over 3.5-5 hours daily for four 
consecutive days on week 1.  Patients then receive SU101 IV over 3.5-5 hours 
weekly for weeks 2-11 followed by one week of rest and evaluation. Additional 
courses of treatment consist of SU101 IV over 3.5-5 hours weekly on weeks 1-11 
followed by one week of rest and evaluation. Treatment continues for up to 1 
year in the absence of unacceptable toxicity and disease progression. 

Patients are followed at 30 days after last treatment. In addition, patients 
off study treatment are contacted every 2 months while the study is in 
progress to assess the status of their disease.

Trial Contact Information

Trial Lead Organizations

SUGEN, Incorporated - South San Francisco

Alison L. Hannah, MBBS, Protocol chair		Ph: 650-553-8415 Email: alisonh@sugen.sf.ca.us