A Study of Radiation With Sorafenib in Advanced Cancer
The purpose of this study is to test the combination of radiation treatment and an anti-angiogenic drug called sorafenib (or BAY 43-9006 or Nexavar) to determine the effects of this combination on cancers but also on side effects of radiation treatment. This study will also determine the highest safe dose of sorafenib that can be given with radiation treatment.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Dose Escalation Study of Concurrent Low Dose Radiation With Sorafenib in Three Anatomically-based Independent Cohorts (Thorax, Abdomen, Pelvis)|
- To measure safety and maximum tolerated dose, all adverse events will be assessed in line with dose limiting toxicities. [ Time Frame: Outcome is measured prior to each dose escalation. ] [ Designated as safety issue: Yes ]
- To assess the efficacy of adding sorafenib to radiation treatment, radiological imaging will be used to assess response rate inline with the RECIST criteria. [ Time Frame: 12 weeks from initiation of study treatment. ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Sorafenib orally for one week prior to radiation, then concomitantly for two weeks with radiation and then for one week following completion of radiation. Each anatomic cohort will dose escalate independently. Dose level 1 is 200mg of sorafenib. If full oral dose (400mg orally, twice a day) is reached in a given cohort then an additional dose level will open where sorafenib treatment is extended following radiation for a total of eight weeks.
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Anthony Brade||Princess Margaret Hospital, Canada|