Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma

NCT01070186 | Withdrawn Phase 2 DMC

• 1 other identifier: 09-07-068
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Renal Cell Carcinoma

Keywords

nephrectomy; T1b; T2; T3; T4; N1; Kidney Cancer

Outcome Measures

Primary Outcomes (1)

• Time to clinical recurrence after surgery for high risk localized disease.

  1 year

Secondary Outcomes (3)

• Toxicity of Sunitinib when administered as neoadjuvant therapy prior to surgery

  1 year

• 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

• Radiographically quantifiable evaluation of changes in cellular disorganization (marker of necrosis) and perfusion parameters before and during the administration of Sunitinib.

  1 year

Study Arms (1)

Treatment

EXPERIMENTAL

See intervention descriptions

Drug: Sunitinib; Other: Tumor biopsy; Procedure: Nephrectomy; Other: Biomarkers

Interventions

Sunitinib DRUG

50mg/day for 4 weeks

Also known as: Sutent

Treatment

Tumor biopsy OTHER

Conducted prior to administration of sunitinib therapy

Treatment

Nephrectomy PROCEDURE

Nephrectomy 2-4 weeks after last dose of Sunitinib

Treatment

Biomarkers OTHER

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Pfizer: collaborator

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Sunitinib; Nephrectomy; Biomarkers

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Biological Factors

Study Officials

• Fairooz Kabbinavar, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 17, 2010
• Study Start: October 1, 2010
• Last Updated: July 31, 2012

Record last verified: 2012-07