Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Measuring Effects of Pazopanib Hydrochloride in Patients With Metastatic Kidney Cancer

NCT01599832 | Terminated Results

• 2 other identifiers: 12-0121NCI-2012-00676
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to find out what effects pazopanib (pazopanib hydrochloride) (also called Votrient®) may have on MRI (magnetic resonance imaging) scans, blood pressure, and various proteins in the blood. Pazopanib is Food and Drug Administration (FDA) approved for treating renal cell cancer. It is an agent that prevents angiogenesis, which is new blood vessel formation. The use of pazopanib described in this study is a standard of care, but the additional MRI and blood tests that will be performed are experimental

Conditions

Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Cancer; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Disease Progression

  Specifically, whether the change in K\^trans (the rise from nadir) as a time-dependent covariate, as assessed by the method described in Donner, is associated with disease progression.Progression was assessed using Response Evaluation Criteria in Solid Tumors (Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum recorded since the treatment started OR the appearance of one or more new lesions OR unequivocal progression of existing non-target lesions)

  2 years

Secondary Outcomes (3)

• Change in K^Trans From Baseline

  Baseline and 1, 8, 16, and 24 weeks post-treatment

• Changes in Blood Pressure From Baseline to Post-treatment

  Baseline and 1 week post-treatment

• Changes in sVEGFR2 From Baseline to Post-treatment

  Baseline and 1 week post-treatment

Other Outcomes (1)

• Progression-free Survival

  2 years

Study Arms (1)

Treatment (pazopanib hydrochloride, DCE-MRI)

EXPERIMENTAL

Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.

Drug: pazopanib hydrochloride; Other: laboratory biomarker analysis; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Other: pharmacogenomic studies

Interventions

pazopanib hydrochloride DRUG

Given PO

Also known as: GW786034B, Votrient

Treatment (pazopanib hydrochloride, DCE-MRI)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (pazopanib hydrochloride, DCE-MRI)

dynamic contrast-enhanced magnetic resonance imaging PROCEDURE

Undergo dynamic contrast-enhanced magnetic resonance imaging

Also known as: DCE-MRI

Treatment (pazopanib hydrochloride, DCE-MRI)

pharmacogenomic studies OTHER

Correlative studies

Also known as: Pharmacogenomic Study

Treatment (pazopanib hydrochloride, DCE-MRI)

Eligibility Criteria

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

You may qualify if:

• Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up; procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
• Histologically confirmed diagnosis of clear cell renal cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
• Measurable disease at least 2 cm in the shortest dimension in the abdomen or pelvis
• No clinical contra-indication to contrast enhanced MRI
• No prior pazopanib therapy
• Archived tumor tissue must be provided for all subjects
• Absolute neutrophil count (ANC) \>= 1.5 X 10\^9/L
• Hemoglobin \>= 9 g/dL (5.6 mmol/L); subjects may not have had a transfusion within 7 days of screening assessment
• Platelets \>= 100 X 10\^9/L
• Total bilirubin =\< 1.5 X upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 X ULN; concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN are not permitted
• Estimated glomerular filtration rate (GFR) (modification of renal disease \[MDRD\] equation) \> 30 ml/min
• Urine protein to creatinine ratio (UPC) \< 1; if UPC \>= 1, then a 24-hour urine protein must be assessed; subjects must have a 24-hour urine protein value \< 1 g to be eligible
• A female is eligible to enter and participate in this study if she is of:

You may not qualify if:

• Prior malignancy; Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible
• History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug; screening with CNS imaging studies (computed tomography \[CT\] or MRI) is required only if clinically indicated or if the subject has a history of CNS metastases
• Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
• Active peptic ulcer disease
• Known intraluminal metastatic lesion/s with risk of bleeding
• Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
• Malabsorption syndrome
• Major resection of the stomach or small bowel
• Presence of uncontrolled infection
• Corrected QT interval (QTc) \> 480 msecs using Bazett's formula
• History of any one or more of the following cardiovascular conditions within the past 6 months:
• Cardiac angioplasty or stenting
• Myocardial infarction

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Illinois Cancer Care (Peoria)

Peoria, Illinois, 61615, United States

Location

Related Publications (1)

• Sweis RF, Medved M, Towey S, Karczmar GS, Oto A, Szmulewitz RZ, O'Donnell PH, Fishkin P, Karrison T, Stadler WM. Dynamic Contrast-Enhanced Magnetic Resonance Imaging as a Pharmacodynamic Biomarker for Pazopanib in Metastatic Renal Carcinoma. Clin Genitourin Cancer. 2017 Apr;15(2):207-212. doi: 10.1016/j.clgc.2016.08.011. Epub 2016 Aug 17.

  PMID: 27634566 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

pazopanib; Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Results Point of Contact

• Title: Walter Stadler
• Organization: University of Chicago Comprehensive Cancer Center

wstadler@medicine.bsd.uchicago.edu

(773) 702-4150

Study Officials

• Walter Stadler

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 8, 2017
• Results First Posted: June 8, 2017

Record last verified: 2017-05

Locations

US (4)