Clinical trial NCT00678288: 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.
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: Renal Cell Cancer
Interferon
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-05-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Progression-Free Survival
timeFrame: From start of treatment of the first subject until 14 months later, assessed every 8 weeks
Secondary outcomes:
measure: Response Rate
timeFrame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
measure: Time to Progression
timeFrame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
measure: Duration of Response
timeFrame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
measure: Overall Survival
timeFrame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Other outcomes:
Locations:
city: Salzburg
country: Austria
city: Wien
country: Austria
city: Avignon
country: France
city: Bayonne
country: France
city: Bordeaux
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Nantes
country: France
city: Paris
country: France
city: Paris
country: France
city: Reims
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Vandoeuvre Les Nancy
country: France
city: Cork
country: Ireland
city: Dublin
country: Ireland
city: Aviano
country: Italy
state: Pordenone
city: Legnago
country: Italy
state: Verona
city: Napoli
country: Italy
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Reggio Emilia
country: Italy
city: Gdansk
country: Poland
city: Lublin
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Oviedo
country: Spain
city: Pamplona
country: Spain
city: Valencia
country: Spain
city: Northwood
country: United Kingdom
state: Middlesex
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne and Wear
city: London
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: