A Study of Radiation With Sorafenib in Advanced Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610246
• Other study ID #: TAP
• Secondary ID: DDPDRO-003
• Status: Completed
• Phase: Phase 1
• Start date: May 2007
• Est. completion date: May 2011

Study information

• Verified date: February 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose	To measure safety and maximum tolerated dose, all adverse events will be assessed in line with dose limiting toxicities.	Outcome is measured prior to each dose escalation.
Secondary	Sorafenib with radiation treatment efficacy	To assess the efficacy of adding sorafenib to radiation treatment, radiological imaging will be used to assess response rate inline with the RECIST criteria.	12 weeks from initiation of study treatment.