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Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer

Primary Purpose

Kidney Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

sunitinib malate

neoadjuvant therapy

therapeutic conventional surgery

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Safety of Sunitinib Malate (SM)

Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment.

Safety of Surgery After 90 Days of Treatment With SM

Incident Rate: Intraoperative Complication Rate

Secondary Outcome Measures

Response Rate After 90 Days of Treatment With SM

Full Information

NCT ID

NCT00849186

First Posted

February 20, 2009

Last Updated

January 22, 2015

Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00849186

Brief Title

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

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

Keywords

stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

sunitinib malate

Intervention Description

oral

Intervention Type

Procedure

Intervention Name(s)

neoadjuvant therapy

Intervention Description

Intervention Type

Procedure

Intervention Name(s)

therapeutic conventional surgery

Intervention Description

Surgery

Primary Outcome Measure Information:

Title

Safety of Sunitinib Malate (SM)

Description

Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment.

Time Frame

90 days

Title

Safety of Surgery After 90 Days of Treatment With SM

Description

Incident Rate: Intraoperative Complication Rate

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Response Rate After 90 Days of Treatment With SM

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Willie Underwood, MD

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263-0001

Country

United States

12. IPD Sharing Statement

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Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer

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