AzTrials
AzTrials

Renal Cell CarcinomaPhase 2NCT00480935

A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

A Phase 2 study testing Sunitinib Malate (Sutent) in people with Renal Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.

Terminated

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

Official record
Search all trials

Trial summary

Study Hypothesis: Patients with local renal cell carcinoma who are treated neoadjuvantly with Sutent may show a radiologic response to the study drug (Sutent). The study is looking at the neoadjuvant (pre-surgery) administration of Sutent in patients with localized kidney cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Sunitinib Malate (Sutent)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteCanada
Study dates
Oct 2007to Oct 2011
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Histologically confirmed renal cell carcinoma with a component of clear (conventional) cell histology, which has been assessed with biopsy at screening.
  • Locally confined tumour ≤ 7 cm
  • Has not undergone nephrectomy and is a candidate for surgical treatment of renal cell carcinoma
  • Male or female, 18 years of age or older
  • ECOG performance status 0 or 1
  • Adequate organ function as defined by the following criteria:
Show all 16Show fewer
  • Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) less than or equal to 2.5 x central laboratory upper limit of normal (CL-ULN), or AST and ALT less than or equal to 5 x CL ULN if liver function abnormalities are due to underlying malignancy
  • Total serum bilirubin less than or equal to 1.5 x CL-ULN
  • Absolute neutrophil count (ANC) greater than or equal to 1500/mL
  • Platelets greater than or equal to 100,000/mL
  • Hemoglobin greater than or equal to 9.0 g/dL
  • Serum calcium less than or equal to 12.0 mg/dL
  • Serum creatinine less than or equal to 1.5 x CL-ULN
  • Prothrombin time (PT) less than or equal to 1.5 x CL-ULN
  • Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Who cannot join

  • Prior therapy of any kind for RCC (including nephrectomy, immunotherapy, chemotherapy, radiation, hormonal, or investigational therapy)
  • Abnormal ECG- including long QT/QTc interval, AV block or arrythmia
  • Tumour associated with local extension into adjacent tissues
  • Tumour associated with renal/vena caval thrombus
  • Tumour associated with lymphadenopathy (lymph node > 1 cm)
  • Evidence of rapidly progressive disease or other factors requiring surgery to take place before the 12 weeks scheduled for neoadjuvant treatment
Show all 15Show fewer
  • Major surgery within 4 weeks of commencing study treatment
  • Any toxicity with a NCI CTCAE grade 3 or 4
  • Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer
  • Evidence of metastatic renal cell carcinoma
  • Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
  • Current treatment on another clinical trial
  • Pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University Health Network, Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase II, Single Arm, Prospective Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

Study Hypothesis: Patients with local renal cell carcinoma who are treated neoadjuvantly with Sutent may show a radiologic response to the study drug (Sutent).

The study is looking at the neoadjuvant (pre-surgery) administration of Sutent in patients with localized kidney cancer. The purpose of this research is also to evaluate both the safety and effectiveness of Sutent in this patient population.

Read the detailed description

Sutent will be given at 50 mg once daily for 4 consecutive weeks followed by a 1 week rest period. The dosage may change during the cycle due to possible drug toxicities. The nephrectomy will then take place following a one-week washout period. After surgery, patients will have follow-up visits at 6 weeks and 3 months. Patients will be followed for 3 years after completions to assess late toxicities, time to progression and progression-free survival.

Being tested
Sunitinib Malate (Sutent)
Keywords
Localized, Renal Cell Carcinoma, Neoadjuvant, Sunitinib Malate (Sutent)
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.

  • Sunitinib Malate (Sutent)Drug

    Also called Sutent

    Sutent will be given at 50 mg once daily for 4 consecutive weeks followed by a 1 week washout period. The dosage may change during the cycle due to possible drug toxicities. The nephrectomy will then take place following a one-week washout period.

Study groups in NCT00480935
Study groupRoleWhat they receive
Sunitinib Malate (Sutent)ExperimentalSutent will be given at 50 mg once daily for 4 consecutive weeks followed by a 2 week rest period to comprise a complete cycle of 6 weeks. Patients will then continue on Sutent for another cycle of 4 consecutive weeks
Receives: Drug: Sunitinib Malate (Sutent)

What is being measured

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

  1. To assess the radiologic response rate associated with 1 cycle of Sutent for neoadjuvant treatment of patients with renal cell carcinoma

    Measured: 5 weeks

Secondary outcomes (5)

  1. To assess the change in tumour vascularity in response to 1 cycle of neoadjuvant treatment of patients with renal cell carcinoma

    Measured: 5 weeks

  2. To assess the change in expression of the following tissue markers; PDGF-alpha, PDGF-Beta, Flt-3, VEGFR and c-KIT, as compared to pre-treatment biopsy tissue as well as to stage, gender and age-matched controls

    Measured: 5 weeks

  3. To evaluate the safety and tolerability of Sutent given preoperatively

    Measured: 5 weeks

  4. To assess late toxicities, time to progression, progression free survival, and survival

    Measured: 5 weeks - 3 years

  5. A DNA microarray will be used for gene expression profiling of the tissue harvested at biopsy and surgery to investigate differential expression profiles and their association with Sutent sensitivity or resistance

    Measured: 5 weeks

Timeline

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

  1. First posted31 May 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionOct 2011
  4. Study completionOct 2011

Why it stopped: poor recruitment

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00480935
Sponsor's protocol ID
07-0017-C
Status last verified
Dec 2015
First submitted
29 May 2007
Last updated
9 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22;358(9286):966-70. doi: 10.1016/s0140-6736(01)06103-7.

    PubMed 11583750

  • Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006 Jun 7;295(21):2516-24. doi: 10.1001/jama.295.21.2516.

    PubMed 16757724

  • Volpe A, Panzarella T, Rendon RA, Haider MA, Kondylis FI, Jewett MA. The natural history of incidentally detected small renal masses. Cancer. 2004 Feb 15;100(4):738-45. doi: 10.1002/cncr.20025.

    PubMed 14770429

  • Lamuraglia M, Escudier B, Chami L, Schwartz B, Leclere J, Roche A, Lassau N. To predict progression-free survival and overall survival in metastatic renal cancer treated with sorafenib: pilot study using dynamic contrast-enhanced Doppler ultrasound. Eur J Cancer. 2006 Oct;42(15):2472-9. doi: 10.1016/j.ejca.2006.04.023. Epub 2006 Sep 11.

    PubMed 16965911

  • Marzola P, Degrassi A, Calderan L, Farace P, Nicolato E, Crescimanno C, Sandri M, Giusti A, Pesenti E, Terron A, Sbarbati A, Osculati F. Early antiangiogenic activity of SU11248 evaluated in vivo by dynamic contrast-enhanced magnetic resonance imaging in an experimental model of colon carcinoma. Clin Cancer Res. 2005 Aug 15;11(16):5827-32. doi: 10.1158/1078-0432.CCR-04-2655.

    PubMed 16115922

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib Malate (Sutent) in people with Renal Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.

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 16 inclusion and 15 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 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: poor recruitment). Results are not available in the source record.

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?

To assess the radiologic response rate associated with 1 cycle of Sutent for neoadjuvant treatment of patients with renal cell carcinoma (time frame: 5 weeks). 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 NCT00480935, which also lists 5 linked publications.

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 9 Dec 2015.

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