The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).

Official Title

A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma.

Conditions

Carcinoma, Renal Cell.

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study.

Further Details

Primary Outcome Measures:

  • To compare the progression-free survival in patients treated with SU011248 vs interferon-alfa as first-line systemic therapy

Secondary Outcome Measures:

  • To compare the following between the two treatment groups – objective response rate, overall survival, duration of response, patient-reported outcomes, and safety

Study Start

August 2004

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and above
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • Histologically confirmed renal cell carcinoma of clear cell histology with metastases
  • Evidence of measurable disease by radiographic technique
  • Male or female, 18 years or older
  • ECOG performance status of 0 or 1
  • Resolution of all acute toxicities of prior therapies
  • Adequate organ function

Exclusion Criteria:

  • Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
  • Major surgery or radiation therapy within 4 weeks
  • Severe hemorrhage within 4 weeks
  • Diagnosis of a second malignancy within the last 5 years
  • History of or known brain metastases, spinal cord compression or carcinomatous meningitis
  • Serious acute or chronic illness or recent history of significant cardiac abnormality
  • Pre-existing thyroid abnormality with thyroid function that cannot be controlled by medication
  • Known HIV or AIDS-related illness
  • Current treatment on another clinical trial

Total Enrolment

700

Contact Details

Study centre contact information

  • Pfizer Investigational Site, St. Leonards, New South Wales, 2065, Australia
  • Pfizer Investigational Site, South Brisbane, Queensland, 4101, Australia
  • Pfizer Investigational Site, Woodville South, South Australia, 5011, Australia
  • Pfizer Investigational Site, East Melbourne, Victoria, 3002, Australia

Published results