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Trial record 1 of 1 for:    NCT00480935
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A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00480935
Recruitment Status : Terminated (poor recruitment)
First Posted : May 31, 2007
Last Update Posted : December 9, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE May 29, 2007
First Posted Date  ICMJE May 31, 2007
Last Update Posted Date December 9, 2015
Study Start Date  ICMJE October 2007
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2007)
To assess the radiologic response rate associated with 2 cycles of Sutent for neoadjuvant treatment of patients with renal cell carcinoma [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2011)
  • 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 ]
  • 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 ]
  • To evaluate the safety and tolerability of Sutent given preoperatively [ Time Frame: 5 weeks ]
  • To assess late toxicities, time to progression, progression free survival, and survival [ Time Frame: 5 weeks - 3 years ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2007)
  • To assess the change in tumour vascularity in response to 2 cycles of neoadjuvant treatment of patients with renal cell carcinoma [ Time Frame: 12 weeks ]
  • 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: 12 weeks ]
  • To evaluate the safety and tolerability of Sutent given preoperatively [ Time Frame: 12 weeks ]
  • To assess late toxicities, time to progression, progression free survival, and survival [ Time Frame: 12 weeks - 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma
Official Title  ICMJE A Phase II, Single Arm, Prospective Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE Drug: Sunitinib Malate (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.
Other Name: Sutent
Study Arms  ICMJE Experimental: Sunitinib Malate (Sutent)
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: Drug: Sunitinib Malate (Sutent)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 10, 2013)
3
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2007)
30
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00480935
Other Study ID Numbers  ICMJE 07-0017-C
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Antonio Finelli, MD MSc FRCSC University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP