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

Alternate Title

SU101 in Treating Patients with Recurrent or Metastatic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over Pharmaceutical / Industry SUGEN-SU101.003 NCI-V96-1092

Objectives

I.  Estimate the maximum tolerated dose of SU101, a platelet-derived growth 
factor receptor inhibitor, when given as a loading dose over 4 days followed 
by 11 weekly maintenance doses 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
  GI Tract Cancers

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

Prior/Concurrent Therapy:

At least 4 weeks since any investigational agent

Biologic therapy:
  Recovered from prior immunotherapy

Chemotherapy:
  Recovered from prior chemotherapy

Endocrine therapy:
  Stable hormonal therapy allowed provided therapy begun at least 6 months
  prior to entry

Radiotherapy:
  Recovered from prior radiotherapy

Surgery:
  Not specified

Patient Characteristics:

Age:
  18 and over

Performance status:
  Karnofsky 60%-100%

Life expectancy:
  At least 12 weeks

Hematopoietic:
  WBC at least 3,000/mm3  
  ANC at least 1,500/mm3
  Platelet count at least 100,000/mm3
  Hemoglobin at least 9.0 g/dL (maintained without transfusion for 2 weeks)

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

Renal:
  Creatinine no greater than 2 mg/dL OR
  Creatinine clearance at least 40 mL/min

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 pregnant or nursing women
     Negative pregnancy test required of fertile women
  Effective contraception required of fertile patients

Expected Enrollment

Up to 30 patients will be entered.

Outline

This is a dose-finding study.

The first group of 3 patients receives SU101 weekly for 4 weeks.  A second 
course is given following a 2-week rest.

Subsequent groups of 3-6 patients receive SU101 on 4 consecutive days (loading 
dose), then weekly for 11 weeks.  Doses are escalated for each group until the 
maximum tolerated dose is determined.

Patients may continue weekly treatment until disease progression; the loading 
dose is not repeated unless treatment is interrupted for more than 2 weeks.  
Successive courses may be given at the next higher dose provided 3 patients 
initially assigned to that dose have completed 6 weeks of treatment 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

John Marshall, MD, Protocol chair		Ph: 202-444-7064