Pre-Surgical Sutent in Renal Cell Carcinoma (RCC)

NCT00715442 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2007-0511NCI-2012-01678
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical research study is to learn if Sutent® (sunitinib malate), given before surgery, can help control renal cell carcinoma. The safety of sunitinib malate will also be studied.

Conditions

Renal Cell Carcinoma

Keywords

Kidney; Renal Cell Carcinoma; RCC; Sutent; Sunitinib malate; Clear cell; SU011248; Nephrectomy; Surgical removal of kidney; Cytoreductive nephrectomy

Outcome Measures

Primary Outcomes (2)

• Time to progression (TTP)

  TTP is defined as the time interval between treatment starts and disease progression or death, whichever occurred first, assessed each cycle (42 days).

  Baseline start of treatment to disease progression; up to 5 years

• Toxicity of Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC)

  Toxicity defined as any Grade 3 or greater perioperative complications attributable to sunitinib.

  Start of study drug up to 30 days after study drug stopped

Study Arms (1)

Sunitinib + Nephrectomy

EXPERIMENTAL

Sunitinib 50 mg by mouth daily for 28 consecutive days. Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.

Drug: Sunitinib; Procedure: Nephrectomy

Interventions

Sunitinib DRUG

50 mg by mouth daily for 28 consecutive days

Also known as: SU011248, Sunitinib Malate, Sutent

Sunitinib + Nephrectomy

Nephrectomy PROCEDURE

Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.

Also known as: Surgical Removal of Kidney

Sunitinib + Nephrectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically or cytologically confirmed metastatic clear cell RCC who are eligible for cytoreductive nephrectomy. The determination of resectability will ultimately lie in the clinical judgment of the urologist and medical oncologist involved in the care of the patient.
• Measurable disease is defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures \>/= 20 mm with conventional techniques or \>/= 10 mm with spiral CT scan. This does not include primary tumors, which will be removed.
• ECOG performance status \</= 1.
• Patients must have adequate organ and marrow function within 14 days as defined below: a) absolute neutrophil count \>/= 1,500/microL b) platelets \>/= 75,000/microL c) Hgb \> 9.0 g/dL (may be transfused or receive epoetin alfa \[e.g., Epogen®\] to maintain this level) d) total bilirubin \</= 2.0 mg/dl • serum creatinine \</= 1.5 times the upper limit of normal (ULN) e) AST(SGOT) and/or ALT (SGPT) \</= 2.5 X institutional ULN for subjects without evidence of liver metastases f) AST(SGOT) and/or ALT (SGPT) \</= 5 X institutional ULN for subjects with documented liver metastases
• Female patients of childbearing potential (i.e. premenopausal, no hysterectomy) must have a normal plasma beta human chorionic gonadotropin (betaHCG) within 24 hours prior to enrolling in the study due to the possible teratogenic effect. Patients with an elevated betaHCG will undergo appropriate evaluation to rule out pregnancy (i.e. referral to Gyn service, pelvic ultrasound) and if pregnancy is ruled out and elevated betaHCG is determined to be of tumor origin, patients will be permitted to proceed on study.
• Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study, i.e. condoms.
• Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy. The only approved consent is attached to this protocol.

You may not qualify if:

• Patients must not have organ allografts.
• Patients must not have had major surgical procedure, open biopsy, or significant traumatic injury within 14 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study (other than defined by protocol); or fine needle aspirations or core biopsies within 7 days prior to Day 0.
• No prior malignancy is allowed, except for non-melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for 2 years.
• Patients must not have received any prior anticancer therapy for renal cell carcinoma. Radiation therapy is allowed if \> 2 weeks from study drug administration.
• Patients must not be scheduled to receive another experimental drug while on this study. Patients are permitted to be on concomitant bisphosphonates and megestrol acetate.
• Patients must not have a primary brain tumor (excluding meningiomas other benign lesions), any brain metastases, leptomeningeal disease, seizure disorders not controlled with standard medical therapy, history of stroke within the past year.
• History of serious systemic disease, including myocardial infarction or unstable angina within the last 12 months, history of hypertensive crisis or hypertensive encephalopathy, uncontrolled hypertension (blood pressure of \> 140/90 mmHg) at the time of enrollment, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), significant vascular disease or symptomatic peripheral vascular disease.
• Patients must not have history of other diseases, 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.
• Patients receiving any concomitant systemic therapy for renal cell cancer are excluded, but patients taking bisphosphonates and megestrol acetate are not excluded.
• Patients must not require total parenteral nutrition with lipids.
• Patients must not have clinical history of coagulopathy, bleeding diathesis or thrombosis within the past year.
• Patients must not have serious, non-healing wound, ulcer, or bone fracture.
• Pregnancy (positive pregnancy test) or lactation.
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
• Know hypersensitivity to any component of sunitinib.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Pfizer: collaborator

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Gatto F, Bratulic S, Jonasch E, Limeta A, Maccari F, Galeotti F, Volpi N, Lundstam S, Nielsen J, Stierner U. Plasma and Urine Free Glycosaminoglycans as Monitoring and Predictive Biomarkers in Metastatic Renal Cell Carcinoma: A Prospective Cohort Study. JCO Precis Oncol. 2023 Feb;7:e2200361. doi: 10.1200/PO.22.00361.

  PMID: 36848607 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib; Nephrectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney 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

Study Officials

• Eric Jonasch, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

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: July 11, 2008
• First Posted: July 15, 2008
• Study Start: June 24, 2008
• Primary Completion (Estimated): December 4, 2026
• Study Completion (Estimated): December 4, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (2)