stop_circleTerminated/Withdrawn

Carcinoma, Renal Cell

Bayer Identifier:

12782

ClinicalTrials.gov Identifier:

NCT00678288

EudraCT Number:

2007-005083-28

EU CT Number:

Not Available
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.

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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%).
  • - Patient should be excluded if they have unresolved chronic toxicity grade
    - > 1 and related to prior therapy with sunitinib.

Trial summary

Enrollment Goal
16
Trial Dates
April 2008 - June 2009
Phase
Phase 2
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hôpital Saint André - BordeauxBORDEAUX, 33000, France
Completed
Clinique Paulmy - BayonneBAYONNE, 64100, France
Completed
Clinique de Courlancy ReimsReims, 51100, France
Completed
Wojskowy Instytut MedycznyWarszawa, 04-141, Poland
Completed
Akademicki Szpital Kliniczny im. J. Mikulicza-RadeckiegoWroclaw, 50 - 556, Poland
Completed
Wojewodzkie Centrum OnkologiiGdansk, 80-219, Poland
Completed
Centrum Onkologii Ziemi LubelskiejLublin, 20-090, Poland
Completed
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Completed
Royal Marsden Hospital (London)London, SW3 6JJ, United Kingdom
Completed
Mount Vernon HospitalNorthwood, HA6 2RN, United Kingdom
Completed
Cochin - ParisPARIS, 75014, France
Completed
CLINIQUE SAINTE CATHERINEAvignon, 84000, France
Completed
Hôpital de la Pitié-Salpétrière - ParisPARIS, 75651, France
Completed
IRCCS Policlinico San MatteoPavia, 27100, Italy
Completed
IRCCS Centro di Riferimento Oncologico - CROAviano, 33081, Italy
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Terminated
Newcastle General HospitalNewcastle Upon Tyne, NE4 6BE, United Kingdom
Terminated
CENTRE CATHERINE DE SIENNENANTES, 44020, France
Terminated
Centre Alexis Vautrin - Vandoeuvre les NancyVANDOEUVRE LES NANCY, 54000, France
Terminated
Institut Claudius Regaud - ToulouseTOULOUSE, 31052, France
Terminated
Hôpital de la Timone - MarseilleMarseille, 13385, France
Terminated
Clinique de l'OrangerieSTRASBOURG, 67000, France
Terminated
Hôpital du Nord - MarseilleMARSEILLE, 13015, France
Terminated
A.O.U. di PerugiaPerugia, 06156, Italy
Terminated
A.O.R.N. Antonio CardarelliNapoli, 80131, Italy
Terminated
A.O. di Reggio EmiliaReggio Emilia, 42100, Italy
Terminated
AULSS 21 Legnago - VenetoLegnago, 37045, Italy
Terminated
Hospital Central de AsturiasOviedo, 33006, Spain
Terminated
Clínica Universitaria de NavarraPamplona, 31008, Spain
Terminated
Instituto Valenciano de OncologíaValencia, 46009, Spain
Terminated
Hospital General Universitario Gregorio MarañónMadrid, 28046, Spain
Terminated
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Terminated
Landeskrankenhaus SalzburgSalzburg, 5020, Austria
Terminated
Tallaght HospitalDublin, 24, Ireland
Terminated
Bon Secours HospitalCork, Ireland

Primary Outcome

  • Progression-Free Survival
    date_rangeTime Frame:
    From start of treatment of the first subject until 14 months later, assessed every 8 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Response Rate
    date_rangeTime Frame:
    From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
    enhanced_encryption
    Safety Issue:
    No
  • Time to Progression
    date_rangeTime Frame:
    From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Response
    date_rangeTime Frame:
    From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
    enhanced_encryption
    Safety Issue:
    No
  • Overall Survival
    date_rangeTime Frame:
    From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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