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A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

This study has been terminated.
(poor recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00480935
First Posted: May 31, 2007
Last Update Posted: December 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
University Health Network, Toronto
  Purpose

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.


Condition Intervention Phase
Renal Cell Carcinoma Drug: Sunitinib Malate (Sutent) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single Arm, Prospective Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 3
Study Start Date: October 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480935


Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Pfizer
Investigators
Principal Investigator: Antonio Finelli, MD MSc FRCSC University Health Network, Toronto
  More Information

Publications:
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00480935     History of Changes
Other Study ID Numbers: 07-0017-C
First Submitted: May 29, 2007
First Posted: May 31, 2007
Last Update Posted: December 9, 2015
Last Verified: December 2015

Keywords provided by University Health Network, Toronto:
Localized
Renal Cell Carcinoma
Neoadjuvant
Sunitinib Malate (Sutent)

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors