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

• Sponsor: Roswell Park Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00849186
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 32
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Drug: sunitinib malate; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: sunitinib malate; oral; Procedure: neoadjuvant therapy; IV; Procedure: therapeutic conventional surgery; Surgery

Outcome Measures

Primary Outcome Measures

1. Safety of Sunitinib Malate (SM) [90 days]

   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.

2. Safety of Surgery After 90 Days of Treatment With SM [90 days]

   Incident Rate: Intraoperative Complication Rate

Secondary Outcome Measures

1. Response Rate After 90 Days of Treatment With SM [90 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001

Sponsors and Collaborators

• Roswell Park Cancer Institute
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Willie Underwood, MD, Roswell Park Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT00849186
• Other Study ID Numbers: CDR0000634770; P30CA016056; RPCI-I-95206
• First Posted: Feb 23, 2009
• Last Update Posted: Feb 6, 2015
• Last Verified: Jan 1, 2015

• 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: Kidney Neoplasms; Carcinoma, Renal Cell; Sunitinib

Study Results

Participant Flow

Arm/Group Title	Sunitinib Malate (Sunitinib)
Arm/Group Description	sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery neoadjuvant therapy: IV therapeutic conventional surgery: Surgery
Period Title: Overall Study
STARTED	26
COMPLETED	16
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Sunitinib Malate (Sunitinib)
Arm/Group Description	sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery neoadjuvant therapy: IV therapeutic conventional surgery: Surgery
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.24 (9.57)
Sex: Female, Male (Count of Participants)
Female	9 45%
Male	11 55%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All treated and eligible patients

Arm/Group Title	Sunitinib Malate (Sunitinib)
Arm/Group Description	sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery neoadjuvant therapy: IV therapeutic conventional surgery: Surgery
Measure Participants	20
Number (95% Confidence Interval) [proportion of participants]	.350 1.8%

2. Primary Outcome

Title	Safety of Surgery After 90 Days of Treatment With SM
Description	Incident Rate: Intraoperative Complication Rate
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

All treated and eligible patients

Arm/Group Title	Sunitinib Malate (Sunitinib)
Arm/Group Description	sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery neoadjuvant therapy: IV therapeutic conventional surgery: Surgery
Measure Participants	20
Number (95% Confidence Interval) [proportion of participants]	.150 0.8%

3. Secondary Outcome

Title	Response Rate After 90 Days of Treatment With SM
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

All treated and eligible patients

Arm/Group Title	Sunitinib
Arm/Group Description	sunitinib malate: oral neoadjuvant therapy: IV therapeutic conventional surgery: Surgery
Measure Participants	20
Number (95% Confidence Interval) [proportion of participants]	.20 1%

Adverse Events

Arm/Group Title	Sunitinib
Arm/Group Description	sunitinib malate: oral neoadjuvant therapy: IV therapeutic conventional surgery: Surgery
All Cause Mortality
	Sunitinib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sunitinib
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Sunitinib
	Affected / at Risk (%)	# Events
Total	20/20 (100%)
Blood and lymphatic system disorders
Anaemia	1/20 (5%)	1
Leukopenia	7/20 (35%)	7
Neutropenia	4/20 (20%)	4
Thrombocytopenia	8/20 (40%)	8
White blood cell disorder	1/20 (5%)	1
Eye disorders
Conjunctivitis	1/20 (5%)	1
Vision blurred	1/20 (5%)	1
Gastrointestinal disorders
Abdominal distension	1/20 (5%)	1
Abdominal pain	4/20 (20%)	4
Abdominal pain upper	3/20 (15%)	3
Constipation	1/20 (5%)	1
Diarrhoea	6/20 (30%)	6
Dyspepsia	6/20 (30%)	6
Flatulence	4/20 (20%)	4
Gingival pain	1/20 (5%)	1
Nausea	8/20 (40%)	8
Oral discomfort	2/20 (10%)	2
Paraesthesia oral	1/20 (5%)	1
Stomatitis	3/20 (15%)	3
Toothache	1/20 (5%)	1
Vomiting	4/20 (20%)	5
General disorders
Chest discomfort	1/20 (5%)	1
Chest pain	1/20 (5%)	1
Chills	1/20 (5%)	1
Fatigue	12/20 (60%)	13
Influenza like illness	1/20 (5%)	1
Mucosal inflammation	2/20 (10%)	2
Pyrexia	1/20 (5%)	1
Infections and infestations
Urinary tract infection	2/20 (10%)	2
Injury, poisoning and procedural complications
Depression postoperative	1/20 (5%)	1
Urinary retention postoperative	1/20 (5%)	1
Investigations
Alanine aminotransferase increased	2/20 (10%)	2
Aspartate aminotransferase increased	8/20 (40%)	8
Blood alkaline phosphatase increased	1/20 (5%)	1
Blood amylase	1/20 (5%)	1
Blood amylase increased	2/20 (10%)	2
Blood creatinine	1/20 (5%)	1
Blood creatinine decreased	1/20 (5%)	1
Lipase	1/20 (5%)	1
Lipase increased	6/20 (30%)	6
Metabolism and nutrition disorders
Hyperglycaemia	3/20 (15%)	3
Hyperkalaemia	2/20 (10%)	2
Hypocalcaemia	1/20 (5%)	1
Hyponatraemia	1/20 (5%)	1
Musculoskeletal and connective tissue disorders
Back pain	4/20 (20%)	4
Musculoskeletal chest pain	1/20 (5%)	1
Pain in extremity	1/20 (5%)	1
Nervous system disorders
Dizziness	2/20 (10%)	3
Dysgeusia	2/20 (10%)	2
Headache	4/20 (20%)	4
Hypogeusia	1/20 (5%)	1
Paraesthesia	1/20 (5%)	1
Syncope	1/20 (5%)	1
Renal and urinary disorders
Dysuria	1/20 (5%)	1
Urinary hesitation	1/20 (5%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/20 (5%)	1
Pharyngolaryngeal pain	1/20 (5%)	1
Skin and subcutaneous tissue disorders
Alopecia	1/20 (5%)	1
Dermatitis	1/20 (5%)	1
Dry skin	2/20 (10%)	2
Exfoliative rash	1/20 (5%)	1
Palmar-plantar erythrodysaesthesia syndrome	4/20 (20%)	4
Rash	1/20 (5%)	1
Surgical and medical procedures
Arteriovenous fistula operation	1/20 (5%)	1
Vascular disorders
Hypertension	5/20 (25%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.