A Study of Radiation With Sorafenib in Advanced Cancer
This study has been completed.
Sponsor:
University Health Network, Toronto
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00610246
First received: January 24, 2008
Last updated: October 19, 2011
Last verified: October 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: Sorafenib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by University Health Network, Toronto:
Primary Outcome Measures:
- To measure safety and maximum tolerated dose, all adverse events will be assessed in line with dose limiting toxicities. [ Time Frame: Outcome is measured prior to each dose escalation. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess the efficacy of adding sorafenib to radiation treatment, radiological imaging will be used to assess response rate inline with the RECIST criteria. [ Time Frame: 12 weeks from initiation of study treatment. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | May 2007 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610246
Locations
| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
Sponsors and Collaborators
University Health Network, Toronto
Investigators
| Principal Investigator: | Anthony Brade | Princess Margaret Hospital, Canada |
More Information
No publications provided
| Responsible Party: | Dr Anthony Brade, Princess Margaret Hospital |
| ClinicalTrials.gov Identifier: | NCT00610246 History of Changes |
| Other Study ID Numbers: | TAP, 07-0097-C |
| Study First Received: | January 24, 2008 |
| Last Updated: | October 19, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
Thorax Abdomen Pelvis Lesion Cancer Radiation |
Chemotherapy Phase 1 Advanced Cancer Sorafenib Nexavar BAY43-9006 |
Additional relevant MeSH terms:
|
Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013