Sorafenib in Treating Patients Undergoing Surgery for Stage II, Stage III, or Stage IV Kidney Cancer

NCT00405366 | Completed Early Phase 1 DMC

• 2 other identifiers: LCCC 0603CDR0000550127
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying the side effects and how well sorafenib works in treating patients undergoing surgery for stage II, stage III, or stage IV kidney cancer.

Conditions

Kidney Cancer

Keywords

stage II renal cell cancer; stage III renal cell cancer; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (2)

• Number of subjects experiencing adverse events while taking sorafenib prior to nephrectomy

  Adverse events will be assessed (graded) using CTCAE criteria

  8 weeks

• Feasibility of neoadjuvant systemic therapy prior to nephrectomy

  Feasibility will be measured by the proportion of patients who complete therapy

  8 weeks

Secondary Outcomes (2)

• Response in primary renal tumors

  8 weeks

• Effects of sorafenib tosylate therapy on gene expression, protein expression, and metabolic profile

  8 weeks

Study Arms (1)

Single Arm Study

OTHER

Drug: sorafenib tosylate

Interventions

sorafenib tosylate DRUG

Patients will receive treatment with 400mg of sorafenib, orally, twice daily, on a continuous basis as a single agent for at least 4 weeks, but not more than 8 weeks prior to their scheduled nephrectomy

Single Arm Study

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of renal cell carcinoma (RCC) as confirmed by either of the following: * Radiographic documentation by MRI or CT scan * Histological evidence of primary RCC * Stage II-IV disease, as defined by any of the following: * T \> 7 cm * Renal vein involvement * Local invasion * Evidence of lymph node involvement * Distant metastatic disease * Deemed suitable for nephrectomy by a urologist * No requirement for surgery earlier than 4 weeks from study entry * No known brain metastasis * Patients with neurological symptoms must undergo a CT scan or brain MRI to exclude brain metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Hemoglobin ≥ 9.0 g/dL * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement) * Creatinine ≤ 2.5 times ULN or glomerular filtration rate ≥ 50 mL/min * INR ≤ 1.5 AND PTT normal * Stable INR required at baseline for patients on warfarin * Not pregnant or nursing * Negative pregnancy test * Fertile women must use effective contraception * Fertile men must use effective contraception during and for ≥ 2 months after the last dose of sorafenib tosylate * No other active primary malignancy except skin cancer * No active coronary artery disease * No active bleeding diathesis * Closely monitored therapeutic anticoagulation allowed * No cardiac disease, including any of the following: * New York Heart Association class III-IV congestive heart failure * Unstable angina (i.e., anginal symptoms at rest) or new onset angina (i.e., beginning within the past 3 months) * Myocardial infarction within the past 6 months * No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * No uncontrolled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg or diastolic BP \> 90 mm Hg, despite optimal medical management * No known HIV infection or chronic hepatitis B or C * No active, clinically serious infection \> grade 2 * No thrombolic or embolic events, such as a cerebrovascular accident or transient ischemic attacks, within the past 6 months * No pulmonary hemorrhage or bleeding event ≥ grade 2 within the past 4 weeks (≥ grade 3 for any nonpulmonary hemorrhage or bleeding event) * No serious nonhealing wound, ulcer, or bone fracture * No significant traumatic injury within the past 4 weeks * No known or suspected allergy to sorafenib tosylate or any agent given in the course of this study * No condition that impairs the patient's ability to swallow whole pills * No malabsorption problem PRIOR CONCURRENT THERAPY: * No major surgery or open biopsy within the past 4 weeks * Concurrent anticoagulation therapy (e.g., warfarin or heparin) allowed * No other concurrent investigational or commercial agents or therapies for RCC * No concurrent Hypericum perforatum (St. John's wort) or rifampin

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Doris Duke Charitable Foundation: collaborator
• Bayer: collaborator
• Amgen: collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Sorafenib

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)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• W. Kimryn Rathmell, MD, PhD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 30, 2006
• Study Start: November 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2015
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

US (1)