Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2007-05-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sorafenib and Radiation
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.
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.
Interventions
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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 Criteria
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Inclusion Criteria
* A measurable lesion in the thorax, abdomen or pelvis.
* Normal organ and bone marrow function.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Anthony Brade
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Hospital, Canada
Locations
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Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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DDPDRO-003
Identifier Type: OTHER
Identifier Source: secondary_id
TAP
Identifier Type: -
Identifier Source: org_study_id
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