A Study of Radiation With Sorafenib in Advanced Cancer

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT00610246

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: Sorafenib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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)

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sorafenib and Radiation Eligible patients (not candidates for curative treatment) will have measurable lesions in the anatomic thorax, abdomen or pelvis (any histology) amenable to palliative radiation treatment (30 Gy in 10 fractions). Patients receive 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. If full oral dose (400 mg po bid) is reached in a given cohort (dose level three) then an additional dose level will open where sorafenib treatment (400 mg bid) is extended following radiation for a total of eight weeks.	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.

Arm

Intervention/Treatment

Experimental: Sorafenib and Radiation

Eligible patients (not candidates for curative treatment) will have measurable lesions in the anatomic thorax, abdomen or pelvis (any histology) amenable to palliative radiation treatment (30 Gy in 10 fractions). Patients receive 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. If full oral dose (400 mg po bid) is reached in a given cohort (dose level three) then an additional dose level will open where sorafenib treatment (400 mg bid) is extended following radiation for a total of eight weeks.

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.

Outcome Measures

Primary Outcome Measures

Maximum Tolerated Dose [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 Outcome Measures

Sorafenib with radiation treatment efficacy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.