Clinical trial NCT00849186: Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer
Official title: A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Cancer
Keywords: stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-02-23
Enrollment: 20
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: Sunitinib 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. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying the side effects of giving sunitinib before surgery and to see how well it works in treating patients with localized or metastatic kidney cancer.

Detailed description: OBJECTIVES:

Primary

* Determine the safety of sunitinib malate in patients with localized or metastatic renal cell carcinoma.
* Determine the safety of surgery after 90 days of treatment with sunitinib malate in these patients.

Secondary

* Determine response of these patients after 90 days of treatment with sunitinib malate.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-90 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical nephrectomy.

After completion of study treatment, patients are followed for 3 months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Newly diagnosed renal cell carcinoma

  * Clinical stage T1b, T2, or T3 tumor with or without nodal or hematogenous metastasis
  * Localized or metastatic disease by renal biopsy
* Primary tumor must be amenable to surgical removal
* No history of or known spinal cord compression or carcinomatous meningitis OR evidence of symptomatic brain or leptomeningeal disease by CT scan or MRI

  * Treated, stable, and asymptomatic brain metastases are allowed

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* ANC ≥ 1,500/mm\^3
* Platelets ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver function abnormalities are due to underlying malignancy)
* Total bilirubin ≤ 1.5 times ULN
* Creatinine \< 2 mg/dL OR creatinine clearance \> 40 mL/min
* Calcium ≤ 10.2 mg/dL
* QTc interval \< 500 msec
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 3 (male)-6 (female) months after completion of study treatment
* No serious intercurrent illness including, but not limited to, any of the following:

  * Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina)
  * New York Heart Association ≥ class II congestive heart failure
  * Serious cardiac arrhythmia requiring medication
  * Peripheral vascular disease ≥ grade 2
  * Psychiatric illness/social situations that would limit compliance with study requirements
* None of the following conditions within the past 6 months:

  * Myocardial infarction
  * Severe/unstable angina
  * Coronary/peripheral artery bypass graft
  * Symptomatic congestive heart failure
  * Cerebrovascular accident or transient ischemic attack
  * Pulmonary embolism
* No ongoing cardiac dysrhythmias NCI CTCAE version 3.0 ≥ grade 2
* No hypertension that cannot be controlled by medications (i.e., diastolic blood pressure \> 100 mm Hg despite optimal medical therapy)
* No known HIV positivity

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Safety of Sunitinib Malate (SM)
timeFrame: 90 days
measure: Safety of Surgery After 90 Days of Treatment With SM
timeFrame: 90 days
Secondary outcomes:
measure: Response Rate After 90 Days of Treatment With SM
timeFrame: 90 days
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Willie Underwood, MD
role: PRINCIPAL_INVESTIGATOR
References: