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Sponsored by: |
University Health Network, Toronto |
Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00609934 |
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.
Condition | Intervention | Phase |
Renal Cell Carcinoma |
Drug: Sorafenib Radiation: external beam radiotherapy |
Phase I Phase II |
MedlinePlus related topics: | Cancer Kidney Cancer |
Drug Information available for: | Sorafenib Sorafenib tosylate |
Study Type: | Interventional |
Study Design: | Other, Open Label, Single Group Assignment |
Official Title: | A Phase I/II Study of Sorafenib and Palliative Radiotherapy in Patients With Advanced Renal Cell Carcinoma and Symptomatic Bony Metastases |
Estimated Enrollment: | 36 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have normal organ and marrow function as defined below:
Exclusion Criteria:
Contact: Soo Chin, RN | 416-946-4501 ext 4274 | soo.chin@uhn.on.ca |
Contact: Judy Quintos, RN | 416-946-4501 ext 4731 | judy.quintos@rmp.uhn.on.ca |
Canada, Ontario | |||||
Princess Margaret Hosptial | Recruiting | ||||
Toronto, Ontario, Canada, M5G2M9 | |||||
Principal Investigator: Michael F Milosevic, FRCPC, MD | |||||
Principal Investigator: Amit M Oza, FRCPC, MBBS, MD |
University Health Network, Toronto |
Responsible Party: | Princess Margaret Hospital Drug Development Program ( Dr. Amit Oza ) |
Study ID Numbers: | DDPDRO-004, UHN REB 07-0357-C |
First Received: | January 24, 2008 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00609934 |
Health Authority: | Canada: Ethics Review Committee; Canada: Health Canada |
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