Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer
This study has been completed.
Sponsor:
Roswell Park Cancer Institute
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00849186
First received: February 20, 2009
Last updated: September 21, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Kidney Cancer |
Drug: sunitinib malate Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy |
Resource links provided by NLM:
Further study details as provided by Roswell Park Cancer Institute:
Primary Outcome Measures:
- Safety of sunitinib malate (SM) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- Safety of surgery after 90 days of treatment with SM [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Response rate after 90 days of treatment with SM [ Time Frame: 90 days ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | August 2007 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: sunitinib malate
oral
Procedure: neoadjuvant therapy
IV
Procedure: therapeutic conventional surgery
Surgery
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849186
Locations
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
| Principal Investigator: | Willie Underwood, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00849186 History of Changes |
| Other Study ID Numbers: | CDR0000634770, P30CA016056, RPCI-I-95206 |
| Study First Received: | February 20, 2009 |
| Last Updated: | September 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Roswell Park Cancer Institute:
|
stage I renal cell cancer stage II renal cell cancer stage III renal cell cancer stage IV renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013