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

Case Comprehensive Cancer Center (Case CCC)

Status and phase

Completed

Phase 2

Conditions

Kidney Cancer

Treatments

Drug: sorafenib tosylate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00866320

CASE11805 (Other Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

05-167 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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