Know Cancer

forgot password

A Phase II Study of Sunitinib Malate in Patients With Renal Cell Carcinoma and Unresectable Primary Tumors

Phase 2
18 Years
Open (Enrolling)
Kidney Cancer

Thank you

Trial Information

A Phase II Study of Sunitinib Malate in Patients With Renal Cell Carcinoma and Unresectable Primary Tumors


- To determine the percentage of patients with renal cell carcinoma and unresectable
primary tumors who can achieve sufficient tumor response, according to the operating
surgeon, to undergo nephrectomy after sunitinib therapy.

- To evaluate the safety of sunitinib in patients with renal cell carcinoma and
unresectable primary tumors, including analysis of the morbidity of surgery after
sunitinib therapy

- To evaluate the objective response rate of patients with renal cell carcinoma and
unresectable primary tumors who receive sunitinib therapy.

OUTLINE: Patients are stratified according to the presence of distant metastases (yes vs

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42
days in the absence of disease progression or unacceptable toxicity. Surgery is performed if
and when primary tumor becomes resectable. Patients with residual and/or metastatic disease
may resume sunitinib malate within 8 weeks after surgery.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed renal cell carcinoma (any histology)
meeting 1 of the following criteria:

- Metastatic disease

- No evidence of distant metastatic disease on CT scan of chest/abdomen/pelvis,
bone scan, and brain imaging (CT scan or MRI)

- Unresectable primary tumor due to any of the following factors:

- Large tumor size (> 15 cm)

- Bulky lymphadenopathy (> 4 cm or encasement of renal vessels or great vessels)

- Venous thrombosis (high level/invasive disease requiring inferior vena cava
reconstruction or hypothermic circulatory arrest)

- Proximity to vital structures (e.g., mesenteric vasculature)

- No known brain metastases, spinal cord compression, carcinomatous meningitis, or new
evidence of brain leptomeningeal disease by CT scan or MRI


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

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9.0 g/dL (transfusion allowed)

- Serum calcium ≤ 12.0 mg/dL

- Creatinine ≤ 2.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No evidence of bleeding diathesis or coagulopathy (hematuria from primary renal tumor

- None of the following within the past 6 months:

- Myocardial infarction

- Severe or unstable angina

- Severe peripheral vascular disease (claudication) or procedure on peripheral

- Coronary/peripheral artery bypass graft

- New York Heart Association class II-IV congestive heart failure

- Cerebrovascular accident or transient ischemic attack

- Clinically significant bleeding

- Deep venous thrombosis

- Pulmonary embolism

- No hypertension that cannot be controlled by medications to blood pressure < 160/90
mm Hg

- No known HIV positivity or AIDS

- No other severe acute or chronic medical or psychiatric conditions or laboratory
abnormality that may increase the risk associated with study participation


- See Disease Characteristics

- No prior systemic treatment for renal cell carcinoma

- No other concurrent anticancer agents or therapies, including chemotherapy,
biological response modifiers, hormonal therapy, palliative radiotherapy, or

- No concurrent inducers or inhibitors of CYP3A4

- No other concurrent investigational drugs

- No concurrent participation in another clinical trial

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to sunitinib therapy

Outcome Description:

Defined as a reduction in tumor burden to such an extent that nephrectomy is permitted within 1 year of the start of therapy. No response to sunitinib therapy is defined as a nephrectomy not being permitted within 1 year of the start of therapy or removal from the study for any reason

Outcome Time Frame:

1 year from start of treatment

Safety Issue:


Principal Investigator

Brian I. Rini, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

Related Keywords:

  • Kidney Cancer
  • clear cell renal cell carcinoma
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • papillary renal cell carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland, Ohio  44195