Tivozanib Before Surgery in Treating Patients With Localized Kidney Cancer

NCT01769885 | Withdrawn DMC

• 2 other identifiers: I 220412NCI-2012-03185
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial studies tivozanib before surgery in treating patients with localized kidney cancer. Tivozanib may stop the growth of tumor cells by blocking some of the growth factors needed for cell growth.

Conditions

Stage II Renal Cell Cancer; Stage III Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of conducting a trial of tivozanib in terms of patients completing 2 courses of tivozanib

  Up to 30 days after surgery

Secondary Outcomes (2)

• Short-term efficacy defined as a composite of presence of partial response/stable disease/complete response assessed radiographically and correlated with the nephrectomy specimen per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria

  Up to 30 days after surgery

• Incidence of adverse events evaluated using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Up to 30 days after surgery

Study Arms (1)

Treatment (tivozanib and surgery)

EXPERIMENTAL

Patients receive tivozanib PO QD on days 1-21. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. 25 days after completion of tivozanib, patients undergo curative nephrectomy.

Drug: tivozanib; Procedure: therapeutic conventional surgery

Interventions

tivozanib DRUG

Given PO

Also known as: AV-951, oral VEGF receptor tyrosine kinase inhibitor AV-951

Treatment (tivozanib and surgery)

therapeutic conventional surgery PROCEDURE

Undergo nephrectomy

Treatment (tivozanib and surgery)

Eligibility Criteria

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

You may qualify if:

• Biopsy proven non-metastatic clear cell RCC, as per radiographic studies is T2 - T3a based on the American Joint Committee on Cancer (AJCC) 6th edition criteria
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• Hemoglobin \>= 10 gm/dL
• Absolute neutrophil count (ANC) \>= 1.5 X 10\^9/L
• Platelets \>= 100 X 10\^9/L
• Total bilirubin \< 1.5 X upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 X ULN
• International normalization ratio (INR) \< 1.5
• Activated partial thromboplastin time (aPTT) \< 1.2 X ULN
• Serum creatinine \< 1.5 mg/dL or if \>= 1.5 mg/dL: calculated creatinine clearance (CrCL) \> 30 mL/min based on Cockroft-Gault formula
• Must have the ability to swallow and retain oral medication
• Patients of childbearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
• Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

You may not qualify if:

• Pregnant or nursing female patients
• Unwilling or unable to follow protocol requirements
• Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive tivozanib (solitary kidney, multiple tumors in the same or contralateral kidney)
• Not a candidate for surgery
• Received an investigational agent within 30 days prior to enrollment
• Non-clear cell or sarcomatoid histology
• Patients with metastatic disease at presentation
• Prior therapy with tyrosine kinase inhibitor for RCC
• A second primary malignancy (except squamous and basal cell carcinoma of skin) in the past 3 years
• Active or chronic infections
• Significant cardiovascular disease, including:
• Clinically symptomatic left ventricular failure
• Uncontrolled hypertension: systolic blood pressure of \> 150 mmHg or diastolic blood pressure of \> 100 mmHg documented on 2 consecutive measurements taken at least 24 hours apart
• Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of tivozanib
• History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• AVEO Pharmaceuticals, Inc.: collaborator

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

tivozanib

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

Study Officials

• Saby George

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 17, 2013
• Study Start: March 14, 2013
• Primary Completion: June 14, 2013
• Study Completion: December 2, 2013
• Last Updated: August 15, 2022

Record last verified: 2022-08