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

Kidney Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492258
• Other study ID #: MRC-RE05-SORCE
• Secondary ID: CDR0000553251EUD
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2007
• Last updated: August 9, 2013
• Start date: June 2007
• Est. completion date: December 2012

Study information

• Verified date: April 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1656
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• sorafenib tosylate

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Royal Bournemouth Hospital	Bournemouth	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Queen's Hospital	Burton-upon-Trent	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Gloucestershire Oncology Centre at Cheltenham General Hospital	Cheltenham	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Dorset County Hospital	Dorchester	England
United Kingdom	Gloucestershire Royal Hospital	Gloucester	England
United Kingdom	Diana Princess of Wales Hospital	Grimsby	England
United Kingdom	Princess Royal Hospital at Hull and East Yorkshire NHS Trust	Hull	England
United Kingdom	Ipswich Hospital	Ipswich	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Lincoln County Hospital	Lincoln	England
United Kingdom	Charing Cross Hospital	London	England
United Kingdom	Guy's Hospital	London	England
United Kingdom	Medical Research Council Clinical Trials Unit	London	England
United Kingdom	Royal Marsden - London	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	Maidstone Hospital	Maidstone	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology	Merseyside	England
United Kingdom	James Cook University Hospital	Middlesbrough	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Dorset Cancer Centre	Poole Dorset	England
United Kingdom	Portsmouth Oncology Centre at Saint Mary's Hospital	Portsmouth Hants	England
United Kingdom	Whiston Hospital	Prescot Merseyside	England
United Kingdom	Berkshire Cancer Centre at Royal Berkshire Hospital	Reading	England
United Kingdom	Scarborough General Hospital	Scarborough	England
United Kingdom	Scunthorpe General Hospital	Scunthorpe	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Wexham Park Hospital	Slough, Berkshire	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	University Hospital of North Staffordshire	Stoke-On-Trent	England
United Kingdom	Torbay Hospital	Torquay	England

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival			No
Secondary	Metastasis-free survival			No
Secondary	Disease-specific survival time			No
Secondary	Overall survival			No
Secondary	Cost effectiveness			No
Secondary	Toxicity			Yes