Renal Cell CarcinomaPhase 1/2NCT00609934
Study of Sorafenib and Palliative Radiotherapy in Kidney Cancer That Spreads to the Bone
A Phase 1/2 study testing Sorafenib and external beam radiotherapy in people with Renal Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Sorafenib and external beam radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2007to Oct 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Serious medical condition that might be aggravated by treatment, including but not limited to: myocardial infarction within 6 months, congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled hypertension, uncontrolled psychotic disorders, serious infections, active peptic ulcer disease, active liver disease, or cerebrovascular disease with previous stroke.
- Patients may not be receiving any other investigational agent concurrently or within 4 weeks of study registration. Patients receiving other molecularly-targeted treatments for RCC off of study, including inhibitors of angiogenesis or mTOR, will be eligible for this study after a 1 week wash-out period.
- Patients with clinical or radiological evidence of spinal cord compression are ineligible.
- Patients who are at high risk of pathologic fracture and appropriate for surgical intervention are ineligible.
- Patients who are planned for palliative surgical intervention to the index lesion or adjacent bone are ineligible.
- Pregnant or lactating women are excluded from this study because the safety of sorafenib has not been established in these circumstances.
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- Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib.
- Patients with other active malignancies other than non-melanoma skin cancer are excluded.
- Patients who have had significant surgical procedures requiring a general anaesthetic (for example, open laparotomy or thoracotomy) within the past month
- Patients who possess significant unhealed wounds or ulcers
- Patients with any bleeding or clotting disorder
- Patient taking greater than 325mg of aspirin per day
- Patients with diabetes mellitus will be ineligible for the PET-CT components of the study, but will remain eligible to receive sorafenib.
- Patients who are currently taking rifampin, phenytoin, carbamazepine, Phenobarbital, dexamethasone and St. John's Wort.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study of Sorafenib and Palliative Radiotherapy in Patients With Advanced Renal Cell Carcinoma and Symptomatic Bony Metastases
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.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Sorafenib, external beam radiotherapy
- Keywords
- renal cell carcinoma, kidney cancer, bone metastases, RCC, bone pain, palliative radiotherapy, sorafenib, radiation, renal cell
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called BAY 43-9006, NSC 724772
Dose level 1: sorafenib 200mg PO OD on Days 1-84 Dose level 2: sorafenib 400mg PO OD on Days 1-84
external beam radiotherapyRadiation
3000cGy in 10 fractions
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib and palliative radiotherapy | Experimental | Not described Receives: Drug: Sorafenib; Radiation: external beam radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain from index lesion 4 weeks following the completion of radiotherapy, assessed using Brief Pain Inventory.
Measured: 7 weeks
Secondary outcomes (5)
reduction in pain in index lesion at study termination assessed using Brief Pain Inventory
Measured: 12 weeks
acute toxicity of palliative radiotherapy and sorafenib together
Measured: 12 weeks
acute toxicity of sorafenib alone
Measured: 1 week
biologic response of the index lesion to radiotherapy and sorafenib assessed using FDG-PET-CT
Measured: 7 weeks
disease-free survival
Measured: greater than 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609934
- Sponsor's protocol ID
- DDPDRO-004
- Other IDs
- UHN REB 07-0357-C
- Status last verified
- Jul 2015
- First submitted
- 24 Jan 2008
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Sorafenib and Palliative Radiotherapy in Patients With Advanced Renal Cell Carcinoma and Symptomatic Bony Metastases
- ClinicalTrials.gov ID
- NCT00609934
- Acronym / sponsor ID
- DDPDRO-004
- Conditions
- Renal Cell Carcinoma
- Keywords
- renal cell carcinoma, kidney cancer, bone metastases, RCC, bone pain, palliative radiotherapy, sorafenib, radiation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib and palliative radiotherapy | Experimental | Drug: Sorafenib, Radiation: external beam radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Serious medical condition that might be aggravated by treatment, including but not limited to: myocardial infarction within 6 months, congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled hypertension, uncontrolled psychotic disorders, serious infections, active peptic ulcer disease, active liver disease, or cerebrovascular disease with previous stroke.
- Patients may not be receiving any other investigational agent concurrently or within 4 weeks of study registration. Patients receiving other molecularly-targeted treatments for RCC off of study, including inhibitors of angiogenesis or mTOR, will be eligible for this study after a 1 week wash-out period.
- Patients with clinical or radiological evidence of spinal cord compression are ineligible.
- Patients who are at high risk of pathologic fracture and appropriate for surgical intervention are ineligible.
- Patients who are planned for palliative surgical intervention to the index lesion or adjacent bone are ineligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SorafenibAlso: BAY 43-9006, NSC 724772Dose level 1: sorafenib 200mg PO OD on Days 1-84 Dose level 2: sorafenib 400mg PO OD on Days 1-84 | Drug | Sorafenib and palliative radiotherapy |
| external beam radiotherapy3000cGy in 10 fractions | Radiation | Sorafenib and palliative radiotherapy |
Primary outcome
Reduction in pain from index lesion 4 weeks following the completion of radiotherapy, assessed using Brief Pain Inventory.
Time frame: 7 weeks
5 secondary outcomes
reduction in pain in index lesion at study termination assessed using Brief Pain Inventory
Time frame: 12 weeks
acute toxicity of palliative radiotherapy and sorafenib together
Time frame: 12 weeks
acute toxicity of sorafenib alone
Time frame: 1 week
biologic response of the index lesion to radiotherapy and sorafenib assessed using FDG-PET-CT
Time frame: 7 weeks
disease-free survival
Time frame: greater than 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sorafenib and external beam radiotherapy in people with Renal Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain from index lesion 4 weeks following the completion of radiotherapy, assessed using Brief Pain Inventory. (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.