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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00492258
First received: June 25, 2007
Last updated: August 9, 2013
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Drug: sorafenib tosylate
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metastasis-free survival [ Designated as safety issue: No ]
  • Disease-specific survival time [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Cost effectiveness [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 1656
Study Start Date: June 2007
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492258

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

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00492258     History of Changes
Other Study ID Numbers: MRC-RE05-SORCE, CDR0000553251, EUDRACT ID 2006-006079-19, EU-20734, ISRCTN38934710
Study First Received: June 25, 2007
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
stage I renal cell cancer
clear cell renal cell carcinoma
papillary renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014