A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2011 by University Health Network, Toronto.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Pfizer

Information provided by:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT00480935

First received: May 29, 2007

Last updated: May 12, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 29, 2007

Last Updated Date

May 12, 2011

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Complete list of historical versions of study NCT00480935 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of Sutent given preoperatively [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
To assess late toxicities, time to progression, progression free survival, and survival [ Time Frame: 5 weeks - 3 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Arm (s)

Experimental: Sutent

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2013

Estimated Primary Completion Date

September 2012 (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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Keri Durrant, BSc. PGCR, CCRP	416-946-4501 ext 3431	Keri.Durrant@uhn.on.ca
Contact: Karen Hersey, RN	416-946-2155	Karen.Hersey@uhn.on.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00480935

Other Study ID Numbers ^ICMJE

07-0017-C

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Antonio Finelli/Urologic Oncologist, University Health Network

Study Sponsor ^ICMJE

University Health Network, Toronto

Collaborators ^ICMJE

Pfizer

Investigators ^ICMJE

Principal Investigator:

Antonio Finelli, MD, MSc, FRCSC

University Health Network, Toronto

Information Provided By

University Health Network, Toronto

Verification Date

May 2011

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

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