A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Study Hypothesis: Patients with local renal cell carcinoma who are treated neoadjuvantly with Sutent may show a radiologic response to the study drug (Sutent).

The study is looking at the neoadjuvant (pre-surgery) administration of Sutent in patients with localized kidney cancer. The purpose of this research is also to evaluate both the safety and effectiveness of Sutent in this patient population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Pfizer
• Treatments: Sunitinib

Criteria

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 carcinoma

• 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