Sorafenib in Treating Patients at Risk of Relapse After Undergoing Surgery to Remove Kidney Cancer

August 9, 2013 updated by: Medical Research Council

SORCE: A Phase III Randomised Double-Blind Study Comparing Sorafenib With Placebo in Patients With Resected Primary Renal Cell Carcinoma at High or Intermediate Risk of Relapse

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sorafenib is more effective than a placebo in treating kidney cancer.

PURPOSE: This randomized phase III trial is studying sorafenib to see how well it works compared with a placebo in treating patients at risk of relapse after undergoing surgery to remove kidney cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare disease-free survival of patients with resected primary renal cell carcinoma at high- or intermediate-risk of relapse treated with a placebo for 3 years vs a placebo for 2 years and sorafenib tosylate for 1 year vs sorafenib tosylate for 3 years.

OUTLINE: This is a randomized, placebo-controlled, double-blind, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive oral placebo twice daily for 3 years in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive oral sorafenib tosylate twice daily for 1 year and oral placebo twice daily for 2 years in the absence of disease progression or unacceptable toxicity.
  • Arm III: Patients receive oral sorafenib tosylate twice daily for 3 years in the absence of disease progression or unacceptable toxicity.

Patients in arms I and II with progressive disease may cross over and receive treatment in arm III.

After completion of study treatment, patients are followed periodically.

Study Type

Interventional

Enrollment (Anticipated)

1656

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Bournemouth, England, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Burton-upon-Trent, England, United Kingdom, DE13 0RB
        • Queen's Hospital
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital
      • Cheltenham, England, United Kingdom, GL53 7AN
        • Gloucestershire Oncology Centre at Cheltenham General Hospital
      • Derby, England, United Kingdom, DE1 2QY
        • Derbyshire Royal Infirmary
      • Dorchester, England, United Kingdom, DT1 2JY
        • Dorset County Hospital
      • Gloucester, England, United Kingdom, GL1 3NN
        • Gloucestershire Royal Hospital
      • Grimsby, England, United Kingdom, DN33 2BA
        • Diana Princess of Wales Hospital
      • Hull, England, United Kingdom, HU8 9HE
        • Princess Royal Hospital at Hull and East Yorkshire NHS Trust
      • Ipswich, England, United Kingdom, IP4 5PD
        • Ipswich Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • Leeds Cancer Centre at St. James's University Hospital
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • Lincoln, England, United Kingdom, LN2 5QY
        • Lincoln County Hospital
      • London, England, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital
      • London, England, United Kingdom, SW3 6JJ
        • Royal Marsden - London
      • London, England, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, England, United Kingdom, NW1 2DA
        • Medical Research Council Clinical Trials Unit
      • London, England, United Kingdom, SE1 9RT
        • Guy's Hospital
      • Maidstone, England, United Kingdom, ME16 9QQ
        • Maidstone Hospital
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
        • Northern Centre for Cancer Treatment at Newcastle General Hospital
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
      • Plymouth, England, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Poole Dorset, England, United Kingdom, BH15 2JB
        • Dorset Cancer Centre
      • Portsmouth Hants, England, United Kingdom, PO3 6AD
        • Portsmouth Oncology Centre at Saint Mary's Hospital
      • Prescot Merseyside, England, United Kingdom, L35 5DR
        • Whiston Hospital
      • Reading, England, United Kingdom, RG1 5AN
        • Berkshire Cancer Centre at Royal Berkshire Hospital
      • Scarborough, England, United Kingdom, YO12 6QL
        • Scarborough General Hospital
      • Scunthorpe, England, United Kingdom, DN15 7BH
        • Scunthorpe General Hospital
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Cancer Research Centre at Weston Park Hospital
      • Slough, Berkshire, England, United Kingdom, SL2 4HL
        • Wexham Park Hospital
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Stoke-On-Trent, England, United Kingdom, ST4 7LN
        • University Hospital of North Staffordshire
      • Torquay, England, United Kingdom, TQ2 7AA
        • Torbay Hospital
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Velindre Cancer Center at Velindre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed renal cell carcinoma (RCC)

    • Clear cell or non-clear cell tumors allowed
    • Intermediate- or high-risk disease (Leibovich score 3 to 11)

  • Must have undergone surgery for RCC at least 4 weeks but no more than 3 months prior to study entry

    • No evidence of residual macroscopic disease on post-operative CT scan after resection of RCC

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • WBC > 3,400/mm³
  • Platelet count > 99,000/mm³
  • Creatinine < 2.5 times upper limit of normal (ULN)
  • Liver function tests < 1.5 times ULN
  • Serum amylase < 1.5 times ULN
  • PT/INR < 1.5 times ULN
  • PTT < 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 9 months after completion of study treatment

  • No cardiovascular conditions, including any of the following:

    • Cardiac arrhythmias requiring anti-arrhythmic medication

      • Beta-blockers and digoxin allowed
    • Symptomatic coronary artery disease or ischemia
    • Myocardial infarction within the past 6 months
    • NYHA class II-IV congestive heart failure
  • No active clinically serious bacterial or fungal infection
  • No known history of HIV infection
  • No chronic hepatitis B or C
  • No other prior malignancy except carcinoma in situ of the cervix or adequately treated basal cell carcinoma
  • No uncontrolled hypertension

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior treatment for RCC other than nephrectomy
  • More than 30 days since prior and no other concurrent investigational therapy

  • No concurrent medications that have adverse interactions with sorafenib tosylate including, but not limited to, any of the following:

    • Rifampin
    • Grapefruit juice
    • Ritonavir
    • Ketoconazole
    • Itraconazole
    • Hypericum perforatum (St John's wort)
  • No concurrent bone marrow transplant or stem cell rescue
  • No other concurrent drug that targets angiogenesis, especially VEGF or VEGF receptors (e.g., bevacizumab)
  • No other concurrent drug that targets Ras-pathway or EGFR
  • No other concurrent anticancer therapy (chemotherapy, immunotherapy, signal transduction inhibition, or hormonal therapy)
  • Concurrent non-conventional therapies (e.g., herbs or acupuncture) and vitamin or mineral supplements allowed
  • Concurrent bisphosphonates for prophylaxis of osteoporosis allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Disease-free survival

Secondary Outcome Measures

Outcome Measure
Toxicity
Overall survival
Cost effectiveness
Metastasis-free survival
Disease-specific survival time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Council

Investigators

  • Principal Investigator: Timothy Eisen, Cancer Research UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

June 25, 2007

First Submitted That Met QC Criteria

June 25, 2007

First Posted (ESTIMATE)

June 27, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-RE05-SORCE
  • CDR0000553251 (REGISTRY: PDQ (Physician Data Query))
  • EUDRACT ID 2006-006079-19
  • EU-20734
  • ISRCTN38934710

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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