A Study of Radiation With Sorafenib in Advanced Cancer

NCT00610246 | Completed Phase 1 DMC

• 2 other identifiers: TAPDDPDRO-003
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

Thorax; Abdomen; Pelvis; Lesion; Cancer; Radiation; Chemotherapy; Phase 1; Advanced Cancer; Sorafenib; Nexavar; BAY43-9006

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Sorafenib with radiation treatment efficacy

  12 weeks from initiation of study treatment.

Study Arms (1)

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.

Drug: Sorafenib

Interventions

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.

Sorafenib and Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced cancer not eligible for curative treatment.
• A measurable lesion in the thorax, abdomen or pelvis.
• Normal organ and bone marrow function.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Anthony Brade

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 7, 2008
• Study Start: May 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: May 1, 2011
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

CA (1)