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A Phase II, Single Arm, Prospective Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

Phase 2
18 Years
Open (Enrolling)
Renal Cell Carcinoma

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Trial Information

A Phase II, Single Arm, Prospective Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

Sutent will be given at 50 mg once daily for 4 consecutive weeks followed by a 1 week rest
period. The dosage may change during the cycle due to possible drug toxicities. The
nephrectomy will then take place following a one-week washout period. After surgery,
patients will have follow-up visits at 6 weeks and 3 months. Patients will be followed for
3 years after completions to assess late toxicities, time to progression and
progression-free survival.

Inclusion Criteria:

- Histologically confirmed renal cell carcinoma with a component of clear
(conventional) cell histology, which has been assessed with biopsy at screening.

- Locally confined tumour ≤ 7 cm

- Has not undergone nephrectomy and is a candidate for surgical treatment of renal cell

- Male or female, 18 years of age or older

- ECOG performance status 0 or 1

- Adequate organ function as defined by the following criteria:

- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase
[SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase
[SGPT]) less than or equal to 2.5 x central laboratory upper limit of normal
(CL-ULN), or AST and ALT less than or equal to 5 x CL ULN if liver function
abnormalities are due to underlying malignancy

- Total serum bilirubin less than or equal to 1.5 x CL-ULN

- Absolute neutrophil count (ANC) greater than or equal to 1500/mL

- Platelets greater than or equal to 100,000/mL

- Hemoglobin greater than or equal to 9.0 g/dL

- Serum calcium less than or equal to 12.0 mg/dL

- Serum creatinine less than or equal to 1.5 x CL-ULN

- Prothrombin time (PT) less than or equal to 1.5 x CL-ULN

- Signed and dated informed consent document indicating that the patient (or legally
acceptable representative) has been informed of all pertinent aspects of the trial
prior to enrollment

- Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures

Exclusion Criteria:

- Prior therapy of any kind for RCC (including nephrectomy, immunotherapy,
chemotherapy, radiation, hormonal, or investigational therapy)

- Abnormal ECG- including long QT/QTc interval, AV block or arrythmia

- Tumour associated with local extension into adjacent tissues

- Tumour associated with renal/vena caval thrombus

- Tumour associated with lymphadenopathy (lymph node > 1 cm)

- Evidence of rapidly progressive disease or other factors requiring surgery to take
place before the 12 weeks scheduled for neoadjuvant treatment

- Major surgery within 4 weeks of commencing study treatment

- Any toxicity with a NCI CTCAE grade 3 or 4

- Diagnosis of any second malignancy within the last 5 years, except for adequately
treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer

- Evidence of metastatic renal cell carcinoma

- Any of the following within the 12 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, or pulmonary embolism

- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
the normal range with medication

- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness

- Current treatment on another clinical trial

- Pregnancy or breastfeeding

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the radiologic response rate associated with 1 cycle of Sutent for neoadjuvant treatment of patients with renal cell carcinoma

Outcome Time Frame:

5 weeks

Safety Issue:


Principal Investigator

Antonio Finelli, MD, MSc, FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Health Canada

Study ID:




Start Date:

October 2007

Completion Date:

January 2013

Related Keywords:

  • Renal Cell Carcinoma
  • Localized
  • Renal Cell Carcinoma
  • Neoadjuvant
  • Sunitinib Malate (Sutent)
  • Carcinoma
  • Carcinoma, Renal Cell