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A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

Primary Purpose

Renal Cell Carcinoma

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Sunitinib Malate (Sutent)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Localized, Renal Cell Carcinoma, Neoadjuvant, Sunitinib Malate (Sutent)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

    • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • University Health Network, Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sunitinib Malate (Sutent)

Arm Description

Sutent 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess the change in tumour vascularity in response to 1 cycle of neoadjuvant treatment of patients with renal cell carcinoma
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
To evaluate the safety and tolerability of Sutent given preoperatively
To assess late toxicities, time to progression, progression free survival, and survival
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

Full Information

First Posted
May 29, 2007
Last Updated
December 7, 2015
Sponsor
University Health Network, Toronto
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00480935
Brief Title
A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma
Official Title
A Phase II, Single Arm, Prospective Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. The purpose of this research is also to evaluate both the safety and effectiveness of Sutent in this patient population.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Localized, Renal Cell Carcinoma, Neoadjuvant, Sunitinib Malate (Sutent)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sunitinib Malate (Sutent)
Arm Type
Experimental
Arm Description
Sutent 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
Intervention Type
Drug
Intervention Name(s)
Sunitinib Malate (Sutent)
Other Intervention Name(s)
Sutent
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To assess the change in tumour vascularity in response to 1 cycle of neoadjuvant treatment of patients with renal cell carcinoma
Time Frame
5 weeks
Title
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
Time Frame
5 weeks
Title
To evaluate the safety and tolerability of Sutent given preoperatively
Time Frame
5 weeks
Title
To assess late toxicities, time to progression, progression free survival, and survival
Time Frame
5 weeks - 3 years
Title
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
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Finelli, MD MSc FRCSC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
11583750
Citation
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.
Results Reference
background
PubMed Identifier
16757724
Citation
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.
Results Reference
background
PubMed Identifier
14770429
Citation
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.
Results Reference
background
PubMed Identifier
16965911
Citation
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. Erratum In: Eur J Cancer. 2007 May;43(8):1336.
Results Reference
background
PubMed Identifier
16115922
Citation
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.
Results Reference
background

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A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

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