A Study of Radiation With Sorafenib in Advanced Cancer

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00610246
First received: January 24, 2008
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: Sorafenib
Phase 1

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 36
Study Start Date: May 2007
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Sorafenib
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.

  Eligibility

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

Inclusion Criteria:

  • Advanced cancer not eligible for curative treatment.
  • A measurable lesion in the thorax, abdomen or pelvis.
  • Normal organ and bone marrow function.
  • Able to receive protocol prescribed radiation. Please refer to the protocol for detailed inclusion criteria.

Exclusion Criteria:

  • Overlap of treatment field with a previous radiation field.
  • Inability to meet mandated normal tissue radiation dose constraints.
  • Brain metastases (unless previously treated and controlled)
  • Previous treatment with Sorafenib.
  • Poorly controlled Hypertension.
  • Unable to swallow sorafenib tablets.
  • Intercurrent cardiac dysfunction.
  • Uncontrolled intercurrent illness. Please refer to the protocol for detailed exclusion criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610246

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Anthony Brade Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: Dr Anthony Brade, Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT00610246     History of Changes
Other Study ID Numbers: TAP, 07-0097-C
Study First Received: January 24, 2008
Last Updated: October 19, 2011
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Thorax
Abdomen
Pelvis
Lesion
Cancer
Radiation
Chemotherapy
Phase 1
Advanced Cancer
Sorafenib
Nexavar
BAY43-9006

Additional relevant MeSH terms:
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014