Study of Sorafenib and Palliative Radiotherapy in Kidney Cancer That Spreads to the Bone

Phase 1

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Drug: Sorafenib; Radiation: external beam radiotherapy

• Registration Number: NCT00609934
• Lead Sponsor: University Health Network, Toronto

Brief Summary

The purpose of this study is to investigate the use of a new anti-angiogenic drug called sorafenib, in combination with radiotherapy, for renal cell cancer that has spread to the bone and is causing significant pain. The study will find a safe dose of sorafenib for this combination study treatment, look at side effects, and test if the study treatment is effective in controlling the pain experienced from this type of renal cell cancer. . There will be two parts or phases to this study

The purpose of the first phase is to find the highest dose of sorafenib that can be given safely to patients, when combined with radiotherapy. We will also see what kind of effects the study treatment has on you and your cancer. Participants in this phase will receive a dose of sorafenib that has shown to be well-tolerated in humans. If the side effects are tolerable for this dose of sorafenib when combined with radiotherapy, new patients will be asked to join the study and will receive a dose of sorafenib higher than the last study participant.

In the second phase, new study participants will receive the dose of sorafenib that was determined to be safe in the first phase. Side effects will continue to be looked at and the effectiveness on controlling pain symptoms from this type of cancer, will also be looked at.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-24
• Study First Submitted QC: 2008-02-06
• Study First Posted: 2008-02-07
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sorafenib and palliative radiotherapy	external beam radiotherapy	-
Sorafenib and palliative radiotherapy	Sorafenib	-

Primary Outcome Measures

Name	Time	Method
Reduction in pain from index lesion 4 weeks following the completion of radiotherapy, assessed using Brief Pain Inventory.	7 weeks

Secondary Outcome Measures

Name	Time	Method
acute toxicity of palliative radiotherapy and sorafenib together	12 weeks
reduction in pain in index lesion at study termination assessed using Brief Pain Inventory	12 weeks
acute toxicity of sorafenib alone	1 week
biologic response of the index lesion to radiotherapy and sorafenib assessed using FDG-PET-CT	7 weeks
disease-free survival	greater than 3 months

Trial Locations

Locations (1)

Princess Margaret Hosptial; 🇨🇦 Toronto, Ontario, Canada