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

NCT00849186 | Completed Results DMC

• 3 other identifiers: CDR0000634770P30CA016056RPCI-I-95206
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  90 days

• Safety of Surgery After 90 Days of Treatment With SM

  Incident Rate: Intraoperative Complication Rate

  90 days

Secondary Outcomes (1)

• Response Rate After 90 Days of Treatment With SM

  90 days

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: sunitinib malate; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery

Interventions

sunitinib malate DRUG

oral

Arm 1

neoadjuvant therapy PROCEDURE

IV

Arm 1

therapeutic conventional surgery PROCEDURE

Surgery

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Sunitinib; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Combined Modality Therapy; Therapeutics

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Willie Underwood, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 23, 2009
• Study Start: August 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: April 1, 2010
• Last Updated: February 6, 2015
• Results First Posted: February 6, 2015

Record last verified: 2015-01

Locations

US (1)