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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over Pharmaceutical / Industry SUGEN-SU101.002 NCI-V96-1090

Objectives

I. Estimate the maximum tolerated dose (MTD) of SU101, a platelet-derived 
growth factor receptor inhibitor, when given as a 24-hour infusion once weekly 
for 4 weeks in patients with advanced solid tumors.

II. Assess the pharmacokinetic and pharmacodynamic profiles of SU101 on this 
schedule.

Entry Criteria

Disease Characteristics:

Radiologically or pathologically confirmed advanced solid tumor for which      
  there is no accepted alternative therapy, including:
 Ovarian cancer        Melanoma
 Lung cancer           Prostate cancer
 Sarcoma               Breast cancer

CNS metastates secondary to an eligible malignancy allowed provided other      
  sites of metastatic disease are present

Prior/Concurrent Therapy:

Biologic therapy:
 At least 4 weeks since immunotherapy

Chemotherapy:
 At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or            
   mitomycin)

Endocrine therapy:
 Not specified

Radiotherapy:
 At least 4 weeks since radiotherapy

Surgery:
 Not specified

Other:
 At least 4 weeks since any investigational agents

Patient Characteristics:

Age:
 18 and over

Performance Status:
 Karnofsky 60-100%

Life Expectancy:
 At least 3 months

Sex:
 Male or Female

Hematopoietic:
 WBC at least 3,000/mm3 OR
 ANC at least 1,500/mm3
 Platelet count at least 100,000/mm3
 Hemoglobin at least 9.0 g/dL

Hepatic:
 Bilirubin less than 1.5 x normal
 AST/ALT no greater than 3.0 x normal
 Alkaline phosphatase no greater than 3.0 x normal

Renal:
 Creatinine no greater than 2 mg/dL

Other:
 No known allergy to etoposide
 No acute or chronic medical or psychiatric condition or laboratory            
   abnormality that increases the risk of protocol treatment or may interfere  
    with interpretation of results
 No second malignancy within 5 years except:
  In situ cancer of the cervix
  Basal cell carcinoma of the skin
 Not pregnant or nursing
 Negative pregnancy test required of fertile women
 Effective contraception required of fertile patients
     

Expected Enrollment

Up to 30 patients will be enrolled.

Outline

This is a dose-finding study.

Groups of 3 to 6 patients receive escalating doses of SU101 as a 24-hour 
intravenous infusion once weekly for 4 to 6 weeks until the MTD is determined.

Additional treatment may be continued at the next higher dose in the absence 
of disease progression provided at least 3 patients initially entered at that 
dose have completed at least 2 treatments and 48 hours of follow-up with no 
unacceptable toxicity.

Patients are followed 1 month after the last infusion of SU101.

Trial Contact Information

Trial Lead Organizations

SUGEN, Incorporated - Redwood City

S. Eckhardt, MD, Protocol chair		Ph: 303-724-3850; 800-473-2288