A Study of Radiation With Sorafenib in Advanced Cancer

University Health Network, Toronto

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: Sorafenib

Study type: Interventional

Funder types: Other

Identifiers

NCT00610246

TAP

DDPDRO-003 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Sorafenib and Radiation

Experimental group

Description:

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.

Treatment:

Drug: Sorafenib