Clinical trial NCT00866320: Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab
Official title: A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma (RCC) Refractory to SU11248 or Bevacizumab Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: clear cell renal cell carcinoma
recurrent renal cell cancer
stage IV renal cell cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-03-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor Burden Reduction Rate (TBRR)
timeFrame: at 8 weeks (2cycles of treatment)
Secondary outcomes:
measure: Overall Survival
timeFrame: followed until progression or death for approximately 3 years
measure: Time to Progression
timeFrame: followed to progression for approximately 3 years
measure: Duration of Overall Response (Tumor Burden Reduction)
timeFrame: followed for overall response for approximately 3 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
city: Dallas
country: United States
facility: Baylor Sammons Cancer Center
state: Texas
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: Brian I. Rini, MD
role: PRINCIPAL_INVESTIGATOR
References: