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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00866320
First received: March 19, 2009
Last updated: February 14, 2012
Last verified: February 2012

March 19, 2009
February 14, 2012
February 2006
December 2009   (final data collection date for primary outcome measure)
Tumor Burden Reduction Rate (TBRR) [ Time Frame: at 8 weeks (2cycles of treatment) ] [ Designated as safety issue: No ]
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.
Tumor burden reduction rate [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00866320 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: followed until progression or death for approximately 3 years ] [ Designated as safety issue: No ]
    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.
  • Time to Progression [ Time Frame: followed to progression for approximately 3 years ] [ Designated as safety issue: No ]

    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.

  • Duration of Overall Response (Tumor Burden Reduction) [ Time Frame: followed for overall response for approximately 3 years ] [ Designated as safety issue: No ]
    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.
  • Toxicity [ Designated as safety issue: Yes ]
  • Time to progression [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab
A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma (RCC) Refractory to SU11248 or Bevacizumab Therapy

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Cancer
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00866320
CASE11805, P30CA043703, CASE11805, 05-167
Yes
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Brian I. Rini, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP