Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active Over 18 Other MRC-RE05-SORCE MRC-RE05-SORCE, EUDRACT ID 2006-006079-19, EU-20734, NCT00492258, SORCE, ISRCTN38934710

Objectives

1. 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.

Entry 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

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

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

Expected Enrollment

Outcomes

Disease-free survival

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

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.

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Timothy Eisen, Principal investigator		Ph: 44-1223-404-191 Email: tgqe2@cam.ac.uk

United Kingdom
England
	Bournemouth
	Royal Bournemouth Hospital NHS Trust
		Tamas Hickish, MD	Ph:  44-1202-704-789
			Email: tamas.hickish@rbch.nhs.uk
	Bristol
	Bristol Haematology and Oncology Centre
		Contact Person	Ph:  44-11-7928-2468
	Burton-upon-Trent
	Queen's Hospital
		Contact Person	Ph:  44-128-356-6333 ext. 5465
	Cambridge
	Addenbrooke's Hospital
		Timothy Eisen	Ph:  44-1223-404-191
			Email: tgqe2@cam.ac.uk
	Cheltenham
	Cheltenham General Hospital
		Contact Person	Ph:  44-845-422-2596
	Derby
	Derbyshire Royal Infirmary
		Prabir Chakraborti, MD	Ph:  44-1332-254843
			Email: prchakraborh@hotmail.com
	Dorchester
	Dorset County Hospital
		Contact Person	Ph:  44-130-525-5274
	Gloucester
	Gloucestershire Royal Hospital
		Contact Person	Ph:  44-845-422-2596
	Grimsby
	Diana Princess of Wales Hospital
		Contact Person	Ph:  44-01482-676584
	Hull
	Princess Royal Hospital at Hull and East Yorkshire NHS Trust
		Contact Person	Ph:  44-148-267-6703
	Ipswich
	Ipswich Hospital
		Christopher Scrase, MD	Ph:  44-147-370-4177
	Leeds
	Leeds Cancer Centre at St. James's University Hospital
		Contact Person	Ph:  44-113-893-8410
	Leicester
	Leicester Royal Infirmary
		Contact Person	Ph:  44-116-258-6294
	Lincoln
	Lincoln County Hospital
		Contact Person	Ph:  44-152-257-2218
	London
	Charing Cross Hospital
		Contact Person	Ph:  44-20-8846-1419
	Guy's Hospital
		Contact Person	Ph:  44-207-188-4247
	Medical Research Council Clinical Trials Unit
		Contact Person	Ph:  44-20-7670-4743
	Royal Marsden - London
		Martin Gore, MD	Ph:  44-20-7808-2198
			Email: martin.gore@rmh.nhs.uk
	Saint Bartholomew's Hospital
		Contact Person	Ph:  44-207-601-8522
	Maidstone
	Maidstone Hospital
		Contact Person	Ph:  44-162-222-5033
	Manchester
	Christie Hospital
		Contact Person	Ph:  44-161-446-3208
		Robert Hawkins, MD	Ph:  44-161-446-3473
			Email: rhawkins@picr.man.ac.uk
	Merseyside
	Clatterbridge Centre for Oncology
		Ernest Marshall, MD	Ph:  44-151-334-1155
	Middlesbrough
	James Cook University Hospital
		Contact Person	Ph:  44-164-285-4736
	Newcastle-Upon-Tyne
	Northern Centre for Cancer Treatment at Newcastle General Hospital
		Contact Person	Ph:  44-191-256-3588
	Northwood
	Mount Vernon Cancer Centre at Mount Vernon Hospital
		Contact Person	Ph:  44-19-2384-4966
	Plymouth
	Derriford Hospital
		Contact Person	Ph:  44-175-251-7939
	Poole Dorset
	Poole Hospital NHS Trust
		Contact Person	Ph:  44-120-244-6088
	Portsmouth Hants
	Portsmouth Oncology Centre at Saint Mary's Hospital
		Contact Person	Ph:  44-239-228-6000 ext. 3896
	Prescot Merseyside
	Whiston Hospital
		Contact Person	Ph:  44-151-334-1155 ext. 4814
	Reading
	Berkshire Cancer Centre at Royal Berkshire Hospital
		Contact Person	Ph:  44-118-987-8348
	Scarborough
	Scarborough General Hospital
		Simon Hawkyard, MD	Ph:  44-1723-342-085
	Scunthorpe
	Scunthorpe General Hospital
		Contact Person	Ph:  44-17-2428-2282 ext. 2263
	Sheffield
	Cancer Research Centre at Weston Park Hospital
		Contact Person	Ph:  44-114-226-5000 ext. 5007
	Slough, Berkshire
	Wexham Park Hospital
		Contact Person	Ph:  44-175-363-3559
	Southampton
	Southampton General Hospital
		Contact Person	Ph:  44-238-079-8639
	Stoke-On-Trent
	University Hospital of North Staffordshire
		Contact Person	Ph:  44-178-255-4176
	Torquay
	Torbay Hospital
		Contact Person	Ph:  44-180-365-5376
Scotland
	Aberdeen
	Aberdeen Royal Infirmary
		Contact Person	Ph:  44-12-2455-3498
Wales
	Cardiff
	Velindre Cancer Center at Velindre Hospital
		Contact Person	Ph:  44-292-061-5888

Registry Information
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
Trial Start Date		2007-06-01
Trial Completion Date		2012-08-01 (estimated)
Registered in ClinicalTrials.gov		NCT00492258
Date Submitted to PDQ		2007-05-30
Information Last Verified		2008-04-29