Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

A Phase IB, Open-Label, Safety Study of the Combination of Sunitinib and Radiation for the Treatment of Patients With Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00437372

Enrollment

Registered

2007-02-21

Start date

2007-03-31

Completion date

2010-12-31

Last updated

2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Head and Neck Cancer, Nervous System Neoplasms, Pelvic Cancer, Thoracic Neoplasms

Keywords

solid tumor, central nervous system, head and neck, thorax, pelvic area

Brief summary

This study is using the combination of radiation and antiangiogenic agents (agents that destroy existing blood vessels) seems to be an approach to tumor cure.

Detailed description

The combination of ionizing radiation and antiangiogenic agents seems to be a counterintuitive approach to tumor cure because oxygen is a potent radiosensitizer and a reduction in oxygen concentration would be expected following a reduction in tumor vasculature after antiangiogenic treatment.

Interventions

DRUGSunitinib

The use of the FDA approved drug sunitinib, used in an off-label manner with external beam radiation therapy.

RADIATIONExternal Beam Radiation Therapy

Radiotherapy will be administered Monday through Friday for a maximum of 8 weeks. Total dose will depend on the patient's disease site.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Minimum 2 week course of radiation therapy * Solid tumors of the central nervous system, head and neck, thorax, and pelvis

Exclusion criteria

* Major surgery or radiation therapy within 4 weeks starting study treatment * Grade 3 hemorrhage within 4 weeks

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the safety and toxicity profile of sunitinib when used with concurrent radiation therapy	2 years	The purpose of this study is to determine the safety of the combination of the antiangiogenic, sunitinib, when combined with external beam radiotherapy.

Secondary

Measure	Time frame	Description
To measure urine VEGF	2 years	Urine VEGF may be a biomarker of response. This translational approach may be useful to determine who benefits from treatment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026