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

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ClinicalTrials.gov Identifier: NCT00492258
Recruitment Status : Completed
First Posted : June 27, 2007
Last Update Posted : August 12, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE June 25, 2007
First Posted Date  ICMJE June 27, 2007
Last Update Posted Date August 12, 2013
Study Start Date  ICMJE June 2007
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2007)
Disease-free survival
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2007)
  • Metastasis-free survival
  • Disease-specific survival time
  • Overall survival
  • Cost effectiveness
  • Toxicity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sorafenib in Treating Patients at Risk of Relapse After Undergoing Surgery to Remove Kidney Cancer
Official Title  ICMJE 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
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Cancer
Intervention  ICMJE
  • Drug: sorafenib tosylate
  • Procedure: adjuvant therapy
Study Arms  ICMJE Not Provided
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 Completed
Estimated Enrollment  ICMJE
 (submitted: June 25, 2007)
1656
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00492258
Other Study ID Numbers  ICMJE MRC-RE05-SORCE
CDR0000553251 ( Registry Identifier: PDQ (Physician Data Query) )
EUDRACT ID 2006-006079-19
EU-20734
ISRCTN38934710
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Medical Research Council
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timothy Eisen Cancer Research UK
PRS Account National Cancer Institute (NCI)
Verification Date April 2008

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