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

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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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

49 participants in 1 patient group

Sorafenib
Experimental group
Description:
Chemotherapy single agent systemic. Sorafenib given up to 600mg orally every 12 hours for up to 10 months (40 weeks).
Treatment:
Drug: sorafenib tosylate

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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