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Completed

NCT Number: NCT00610246

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sorafenib

Drug

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.

Primary outcomes

  1. Maximum Tolerated Dose

    Time frame: Outcome is measured prior to each dose escalation.

    To measure safety and maximum tolerated dose, all adverse events will be assessed in line with dose limiting toxicities.

Secondary outcomes

  1. Sorafenib with radiation treatment efficacy

    Time frame: 12 weeks from initiation of study treatment.

    To assess the efficacy of adding sorafenib to radiation treatment, radiological imaging will be used to assess response rate inline with the RECIST criteria.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

A Phase I Dose Escalation Study of Concurrent Low Dose Radiation With Sorafenib in Three Anatomically-based Independent Cohorts (Thorax, Abdomen, Pelvis)

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Feb 7, 2008
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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