Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab

Kidney Cancer Clinical Trial

Official title:

A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma (RCC) Refractory to SU11248 or Bevacizumab Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866320
• Other study ID #: CASE11805
• Secondary ID: P30CA043703CASE1
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2009
• Last updated: July 14, 2014
• Start date: February 2006
• Est. completion date: December 2009

Study information

• Verified date: July 2014
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with metastatic kidney cancer that has not responded to sunitinib or bevacizumab.

Description:

OBJECTIVES:

Primary

• To determine the tumor burden reduction rate in patients with sunitinib malate- or bevacizumab-refractory, metastatic clear cell renal cell carcinoma treated with sorafenib tosylate.

Secondary

• To determine the safety of sorafenib tosylate in these patients.

• To record the duration of tumor reduction, time to disease progression, and overall survival of patients treated with sorafenib tosylate.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma with a component of clear cell histology

• Metastatic disease

• Disease progression, as defined by RECIST criteria, after prior treatment with sunitinib malate or bevacizumab

• Patients must have received = 1 course (4 weeks) of sunitinib malate or = 2 doses of bevacizumab AND have RECIST-defined objective progression during or within 4 months after completing treatment with sunitinib malate or bevacizumab

• Measurable disease by RECIST criteria

• CNS metastases allowed provided patient has undergone prior surgery and/or radiotherapy AND has no evidence of further CNS disease progression by CT scan or MRI = 2 weeks after treatment of CNS metastases

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%

• WBC = 3,000/µL

• Absolute neutrophil count = 1,500/µL

• Platelet count = 75,000/µL

• Total bilirubin = 1.5 times upper limit of normal (ULN)

• AST/ALT = 2.5 times ULN

• Creatinine = 2.0 times ULN

• Negative pregnancy test

• No significant cardiovascular disease, including any of the following:

• Congestive heart failure (New York Heart Association class III-IV heart disease)

• Active angina pectoris requiring nitrate therapy

• Uncontrolled dysrhythmias

• Cardiovascular event within the past 6 months (e.g., transient ischemic attack/cerebrovascular accident, myocardial infarction, or vascular surgery)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 2 weeks since prior systemic therapy, radiotherapy, or major surgery and recovered

• No prior sorafenib tosylate

• No other concurrent investigational agents

• No other concurrent anticancer therapy

• No concurrent prophylactic growth factors

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• sorafenib tosylate
Sorafenib (BAY 43-9006) is an oral multi-kinase inhibitor targeting both tumor cells and the tumor vasculature. Patients with metastatic RCC meeting eligibility criteria will receive 400 mg BID of sorafenib in a single-arm phase II study. Treatment will be administered on an outpatient basis.

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Baylor Sammons Cancer Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Burden Reduction Rate (TBRR)	The primary endpoint of the study is defined as the percentage of patients who experience larger than or equal to 5% reduction in tumor burden as measured by RECIST-defined target lesions without progression of non-target lesions or the appearance of any new lesions, confirmed at least 4 weeks after first documentation. RECIST criteria will be used for the purpose of designating target lesions, calculating total tumor burden (the sum of the unidimensional measurement of target lesions) and defining disease progression.Additional RECIST-defined partial or complete responses will be recorded.	at 8 weeks (2cycles of treatment)	No
Secondary	Overall Survival	Overall survival measured in months and summarized using the Kaplan-Meier method. This will be calculated from the date of registration on-study to the dates of documented evidence of progression and death, respectively.	followed until progression or death for approximately 3 years	No
Secondary	Time to Progression	Time to objective progression will be measured from the start of treatment until the criteria for RECIST-defined progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline.; Progression-free survival measured in months and summarized using the Kaplan-Meier method.	followed to progression for approximately 3 years	No
Secondary	Duration of Overall Response (Tumor Burden Reduction)	Measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.	followed for overall response for approximately 3 years	No