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| ID | Type | Description | Link |
|---|---|---|---|
| DDPDRO-003 | Other Identifier | Princess Margaret Cancer Centre |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib and Radiation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | To measure safety and maximum tolerated dose, all adverse events will be assessed in line with dose limiting toxicities. | Outcome is measured prior to each dose escalation. |
| Measure | Description | Time Frame |
|---|---|---|
| Sorafenib with radiation treatment efficacy | To assess the efficacy of adding sorafenib to radiation treatment, radiological imaging will be used to assess response rate inline with the RECIST criteria. | 12 weeks from initiation of study treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Brade | Princess Margaret Hospital, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |