AzTrials
AzTrials

Clear Cell Renal Cell CarcinomaNCT01599832

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

A study testing pazopanib hydrochloride, laboratory biomarker analysis and dynamic contrast-enhanced magnetic resonance imaging in people with Clear Cell Renal Cell Carcinoma and Recurrent Renal Cell Cancer, run by University of Chicago at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
pazopanib hydrochloride, laboratory biomarker analysis and dynamic contrast-enhanced magnetic resonance imaging
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
4 sitesUnited States
Study dates
Jun 2012to Dec 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 33Show fewer
  • 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:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:
  • A hysterectomy
  • A bilateral oophorectomy (ovariectomy)
  • A bilateral tubal ligation
  • Is post-menopausal
  • Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L)
  • Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT
  • Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; acceptable contraceptive methods include:
  • Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product
  • Oral contraceptive, either combined or progestogen alone
  • Injectable progestogen
  • Implants of levonorgestrel
  • Estrogenic vaginal ring
  • Percutaneous contraceptive patches
  • Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year
  • Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject
  • Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
  • Not lactating; female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug

Who cannot join

  • 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
Show all 32Show fewer
  • 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
  • Unstable angina
  • Coronary artery bypass graft surgery
  • Symptomatic peripheral vascular disease
  • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
  • Poorly controlled hypertension (defined as systolic blood pressure (SBP) of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90 mmHg); Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP/DBP values from each BP assessment must be < 140/90 mmHg in order for a subject to be eligible for the study
  • History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months; Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
  • Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major)
  • Evidence of active bleeding or bleeding diathesis
  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
  • Hemoptysis in excess of 2.5 mL (or one half teaspoon) within 8 weeks of first dose of study drug
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
  • Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
  • Treatment with any of the following therapies:
  • Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
  • Anti-cancer chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
  • Any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment
  • Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity, except alopecia

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637-1470

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Illinois Cancer Care (Peoria)

    Peoria, Illinois, 61615

Other trials in United States

About this study

Official title: DCE-MRI as Pazopanib Biomarker in Metastatic Renal Cancer

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine whether a K^trans rise from nadir is predictive of subsequent tumor growth.

SECONDARY OBJECTIVES:

  1. To determine the association between changes in mean ambulatory blood pressure measurements, K^trans, and tumor size changes with pazopanib therapy.

II. To determine the association between changes in soluble vascular endothelial growth factor receptor 2 (sVEGFR2) measurements, K^trans, and tumor size changes with pazopanib therapy.

TERTIARY OBJECTIVES:

  1. To explore previously described single nucleotide polymorphisms (SNP's) as pharmacogenomic biomarkers.

II. To model tumor growth kinetics using radiologic tumor size measurements. III. To explore other serum and plasma based putative biomarkers of vascular endothelial growth factor (VEGF) pathway inhibition.

OUTLINE:

Patients receive pazopanib hydrochloride orally (PO) once daily (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.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Being tested
pazopanib hydrochloride, laboratory biomarker analysis, dynamic contrast-enhanced magnetic resonance imaging, pharmacogenomic studies
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pazopanib hydrochlorideDrug

    Also called GW786034B, Votrient

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

  • dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery

    Also called DCE-MRI

    Undergo dynamic contrast-enhanced magnetic resonance imaging

  • pharmacogenomic studiesOther

    Also called Pharmacogenomic Study

    Correlative studies

Study groups in NCT01599832
Study groupRoleWhat they receive
Treatment (pazopanib hydrochloride, DCE-MRI)ExperimentalPatients 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.
Receives: Drug: pazopanib hydrochloride; Other: laboratory biomarker analysis; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Other: pharmacogenomic studies

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 2 years

Secondary outcomes (3)

  1. Change in K^Trans From Baseline

    K^trans is a derived measure from dynamic contrast-enhanced magnetic resonance imaging that reflects perfusion rate and capillary permeability. The change is reported as the log-transformed ratio of K^trans value at follow-up/baseline.

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

  2. Changes in Blood Pressure From Baseline to Post-treatment

    Measured: Baseline and 1 week post-treatment

  3. Changes in sVEGFR2 From Baseline to Post-treatment

    Measured: Baseline and 1 week post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionDec 2015
  4. Study completionDec 2015

Why it stopped: Poor accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01599832
Sponsor's protocol ID
12-0121
Other IDs
NCI-2012-00676
Status last verified
May 2017
First submitted
14 May 2012
Last updated
8 Jun 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 27634566

Questions about this trial

What is this clinical trial studying?

A study testing pazopanib hydrochloride, laboratory biomarker analysis and dynamic contrast-enhanced magnetic resonance imaging in people with Clear Cell Renal Cell Carcinoma and Recurrent Renal Cell Cancer, run by University of Chicago at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Progression (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01599832, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in