Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

Official title:

Phase II, Open Label, Single Center Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01070186
• Other study ID #: 09-07-068
• Status: Withdrawn
• Phase: Phase 2
• First received: February 16, 2010
• Last updated: July 27, 2012
• Start date: October 2010

Study information

• Verified date: July 2012
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to explore the molecular modulatory effect of Sunitinib when given in a neoadjuvant setting prior to radical or partial nephrectomy. The study will evaluate aforementioned outcomes in 30 patients at a dose of 50mg/day for 4 weeks followed by surgery 2-4 weeks following the last dose.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be at least 18 years of age

• Must be eligible to undergo a radical or partial nephrectomy

• Clinical stage T1b, T2, T3, T4 and/or N1 disease as documented by abdomen/pelvis CT scan, or MRI and chest x-ray or CT chest

• Patients must have a performance status on the ECOG scale of 0-1

• Patients must have a pretreatment wbc > 3.0, granulocyte count > 1000/mm3, hemoglobin > 8.5 g/dL, platelet count > 100,000/mm3 and a normal PT and PTT

• Patients must have a serum creatinine < 2.0 mg/dL

• Patients must have adequate hepatic function with a serum bilirubin < upper limit of normal and AST/ALT < 2.5 x upper limit of normal

Exclusion Criteria:

• Radiographic evidence of metastatic disease

• Prior administration of immunotherapy/biotherapy/hormonal or radiation for renal cell carcinoma

• Active secondary malignancies (other than basal cell carcinoma of the skin)

• Serious, nonhealing wound, ulcer, or bone fracture

• Clinically significant cardiovascular disease, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication or Grade II or greater peripheral vascular disease within 1 year preceding Day 0

• Any history or radiologic evidence of central nervous system disease

• Active infection requiring parenteral antibiotics at the time of the first Sunitinib administration

• Current or recent (within the 10 days preceding Day 0) use of oral or parenteral anticoagulants (except as required to maintain patency of preexisting, permanency indwelling IV catheters), or aspirin

• Current, recent (within the 4 weeks preceding Day 0), or planned participation in another experimental drug study

• Screening clinical laboratory values:

• ANC of < 1000/uL

• Platelet count of < 100,000/uL

• Total bilirubin > 2.0 mg/dL

• AST or ALT > 2.5 times the upper limit of normal

• Serum creatinine of > 2.0 mg/dL

• Hemoglobin of < 9 gm/dL (may be transfused to maintain or exceed this level)

• Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2

• Prolonged QTc interval on baseline EKG

• Uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy)

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

• Patients receiving CYP3A4 inducers or inhibitors; patients should not take grapefruit juice or St. John's Wort while on the study

• History of psychiatric disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications

• Unable to take medication by mouth

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• Sunitinib
50mg/day for 4 weeks

Other:
• Tumor biopsy
Conducted prior to administration of sunitinib therapy

Procedure:
• Nephrectomy
Nephrectomy 2-4 weeks after last dose of Sunitinib

Other:
• Biomarkers
Biomarker evaluation of blood prior to treatment, after 4 weeks of Sunitinib administration, and every three months for a year after surgery. Biomarker evaluation of tissue prior to 4 week administration of Sunitinib

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clinical recurrence after surgery for high risk localized disease.		1 year	No
Secondary	Toxicity of Sunitinib when administered as neoadjuvant therapy prior to surgery	Toxicities will be graded using the NCI Common Toxicity Criteria, version 3.0	1 year	Yes
Secondary	Effect of Sunitinib on pretreatment serum levels of Vascular Endothelial Growth Factor (VEGF). Tissue levels (biopsy and pathological specimen) of total VEGF, HIF-alpha, microvessel density, and apoptotic indices (TUNNEL Staining)		1 year	No
Secondary	Radiographically quantifiable evaluation of changes in cellular disorganization (marker of necrosis) and perfusion parameters before and during the administration of Sunitinib.		1 year	No