A Study to Assess Sorafenib Alone and in Combination With Low-Dose Interferon Following Unsuccessful Treatment With Sunitinib in Patients With Advanced Renal Cell Cancer.

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00678288
First received: May 14, 2008
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (MIU) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. In addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator.


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: Sorafenib (Nexavar, BAY43-9006)
Drug: Sorafenib (Nexavar, BAY43-9006) + Interferon
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Open-label, Multicenter, Study Evaluating the Efficacy of Sorafenib Alone and Sorafenib in Combination With Low Dose Interferon Alpha-2a as Second-line Treatment of Sunitinib Failure in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: From start of treatment of the first subject until 14 months later, assessed every 8 weeks ] [ Designated as safety issue: No ]
    Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors [RECIST]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.


Secondary Outcome Measures:
  • Response Rate [ Time Frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks ] [ Designated as safety issue: No ]
    Response Rate was the best tumor response (confirmed Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

  • Time to Progression [ Time Frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks ] [ Designated as safety issue: No ]
    Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.

  • Duration of Response [ Time Frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks ] [ Designated as safety issue: No ]
    Duration of Response was the time from date of first response (Complete Response [CR] or Partial Response [PR]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact.

  • Overall Survival [ Time Frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks ] [ Designated as safety issue: No ]
    Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.


Enrollment: 16
Study Start Date: April 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously
Experimental: Sorafenib (Nexavar, BAY43-9006) + Interferon
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
Drug: Sorafenib (Nexavar, BAY43-9006) + Interferon
Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously. IFN alpha-2a 3MIU FIW s.c., from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.

  Eligibility

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

Inclusion Criteria:

  • Disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria following documented stable disease or better after at least 8 weeks of sunitinib as first-line treatment (or two cycles of 4 weeks on and 2 weeks off treatment)
  • And/or patients who have discontinued sunitinib treatment at any point due to toxicity
  • Study entry at least 2 weeks after treatment with sunitinib but up to a maximum of 8 weeks
  • Memorial Sloane Kettering Cancer Centre (MSKCC) prognostic score low or intermediate
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Patient must have histologically confirmed metastatic renal cell carcinoma with predominant clear cell histology (clear cell component more than 50%).

Exclusion Criteria:

  • Patient should be excluded if they have unresolved chronic toxicity grade
  • > 1 and related to prior therapy with sunitinib.
  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: NCT00678288

Locations
Austria
Salzburg, Austria, 5020
Wien, Austria, 1090
France
Avignon, France, 84000
Bayonne, France, 64100
Bordeaux, France, 33000
Marseille, France, 13015
Marseille, France, 13385
Nantes, France, 44020
Paris, France, 75014
Paris, France, 75651
Reims, France, 51100
Strasbourg, France, 67000
Toulouse, France, 31052
Vandoeuvre Les Nancy, France, 54000
Ireland
Cork, Ireland
Dublin, Ireland, 24
Italy
Aviano, Pordenone, Italy, 33081
Legnago, Verona, Italy, 37045
Napoli, Italy, 80131
Pavia, Italy, 27100
Perugia, Italy, 06156
Reggio Emilia, Italy, 42100
Poland
Gdansk, Poland, 80-219
Lublin, Poland, 20-090
Warszawa, Poland, 04-141
Wroclaw, Poland, 50 - 556
Spain
Barcelona, Spain, 08035
Madrid, Spain, 28041
Madrid, Spain, 28046
Oviedo, Spain, 33006
Pamplona, Spain, 31008
Valencia, Spain, 46009
United Kingdom
Northwood, Middlesex, United Kingdom, HA6 2RN
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE4 6BE
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00678288     History of Changes
Other Study ID Numbers: 12782, 2007-005083-28, CONCERT
Study First Received: May 14, 2008
Results First Received: September 10, 2010
Last Updated: December 4, 2013
Health Authority: Italy: The Italian Medicines Agency
Poland: Ministry of Health
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Austria: Federal Office for Safety in Health Care
Greece: National Organization of Medicines
Ireland: Irish Medicines Board

Keywords provided by Bayer:
Renal Cell Cancer
Interferon

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Sunitinib
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014