Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery

NCT00459979 | Completed Phase 2 Results DMC

• 4 other identifiers: CASE17806P30CA043703CASE-17806CASE-17806-CC209
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sunitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in treating patients with kidney cancer that cannot be removed by surgery.

Conditions

Kidney Cancer

Keywords

clear cell renal cell carcinoma; stage III renal cell cancer; stage IV renal cell cancer; papillary renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Response to Sunitinib Therapy

  Defined as a reduction in tumor burden to such an extent that nephrectomy is permitted within 1 year of the start of therapy. No response to sunitinib therapy is defined as a nephrectomy not being permitted within 1 year of the start of therapy or removal from the study for any reason

  1 year from start of treatment

Secondary Outcomes (6)

• The Number of Patients With Any Type of Complication or Adverse Event

  1 year from start of treatment

• Progression Free Survival

  1 year from start of treatment

• Percent Decrease of Diameter of Primary Tumors

  1 year from start of treatment

• Number of Tumors Which Decreased in Size

  1 year from start of treatment

• Number of Tumors With 30% Reduction in Size

  1 year from start of treatment

Study Arms (1)

Sunitinib

EXPERIMENTAL

Drug: sunitinib malate; Procedure: conventional surgery

Interventions

sunitinib malate DRUG

Sunitinib will be dosed at 50 mg p.o. daily

Also known as: SUNITINIB L-Malate salt, SU010398, PHA-290940AD, Sutent, SUNITINIB

Sunitinib

conventional surgery PROCEDURE

nephrectomy

Sunitinib

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed renal cell carcinoma (any histology) based on prior biopsy or biopsy performed and reviewed at Cleveland Clinic Foundation. This can include pathology read as adenocarcinoma consistent with renal origin.
• Unresectable primary tumor due to any of the following factors or various combinations thereof:
• Large tumor size (\> 15 cm)
• Bulky lymphadenopathy (\> 4 cm or encasement of renal vessels or great vessels)
• Venous thrombosis (high level/invasive disease requiring inferior vena cava reconstruction or hypothermic circulatory arrest)
• Proximity to vital structures (e.g., mesenteric vasculature)
• Any one of these factors may or may not constitute unresectability, but for consideration for this trial, the surgical and medical oncologist must agree that the particular constellation of findings for the patient under consideration would likely entail a low probability (\<50%) that the tumor would be resectable (with negative margins) or that the potential morbidity associated with an attempt at surgical resection would not be clinically acceptable. The numerical thresholds noted above are only a guideline and the clinical judgment of the surgeon and medical oncologist will determine unresectability.
• Patients with history of brain metastases can be enrolled 2 weeks following the completion of gamma knife or whole brain radiotherapy.
• ECOG performance status (PS) 0-1 or Karnofsky PS \>/=70%
• Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 times upper limit of normal (ULN)
• Total Serum Bilirubin ≤ 1.5 times ULN
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
• Serum calcium ≤ 12.0 mg/dL

You may not qualify if:

• The presence of any of the following will exclude a patient from study enrollment:
• Prior systemic treatment for RCC.
• Evidence of bleeding diathesis or coagulopathy. Patients with hematuria from the primary renal tumor are eligible provided all other eligibility criteria are met.
• Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism.
• Hypertension that cannot be controlled by medications to \< 160/90 mmHg.
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
• Pregnancy or breastfeeding.
• Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

• Lane BR, Derweesh IH, Kim HL, O'Malley R, Klink J, Ercole CE, Palazzi KL, Thomas AA, Rini BI, Campbell SC. Presurgical sunitinib reduces tumor size and may facilitate partial nephrectomy in patients with renal cell carcinoma. Urol Oncol. 2015 Mar;33(3):112.e15-21. doi: 10.1016/j.urolonc.2014.11.009. Epub 2014 Dec 19.

  PMID: 25532471 DERIVED

• Rini BI, Garcia J, Elson P, Wood L, Shah S, Stephenson A, Salem M, Gong M, Fergany A, Rabets J, Kaouk J, Krishnamurthi V, Klein E, Dreicer R, Campbell S. The effect of sunitinib on primary renal cell carcinoma and facilitation of subsequent surgery. J Urol. 2012 May;187(5):1548-54. doi: 10.1016/j.juro.2011.12.075. Epub 2012 Mar 14.

  PMID: 22425095 DERIVED

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Brian Rini
• Organization: CCCC

rinib2@ccf.org

216-444-9567

Study Officials

• Brian I. Rini, MD

  Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 11, 2007
• First Posted: April 13, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2013
• Last Updated: March 7, 2014
• Results First Posted: January 7, 2014

Record last verified: 2014-02

Locations

US (1)