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Radiation Therapy (XRT) and ZD6474 in Non-Small Cell Lung Cancer (NSCLC)

NCT00745732 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-11-14

No results posted yet for this study

Summary

Primary Objectives:

* To assess the safety of oral therapy with ZD6474 by evaluating the frequency, severity, and duration of treatment-emergent adverse events in patients with poor prognosis lung cancer.
* To record the extent, frequency and duration of any tumor responses to this treatment regimen and assess whether ZD6474 augments the efficacy of radiation therapy in non-small cell lung cancer patients.
* To determine the recommended phase II dose of ZD6474 for future clinical studies with radiation therapy.

Secondary Objectives:

* To determine the effects on metabolism and angiogenic factors by positron emission tomography (PET) scan/computed tomography (CT) scan , vascular endothelial growth factor (VEGF), and circulating endothelial cell levels in patients treated with ZD6474 and radiation therapy.

Conditions

Interventions

DRUG

ZD6474 (ZACTIMA)

ZD6474 (ZACTIMA) beginning at 100 mg once a day by mouth

RADIATION

Radiation Therapy

Phase I: 45 Gy at 3 Gy per fractions once a day. Phase II: 45 Gy at 3 Gy per fraction once a day or 66-70 Gy at 2 Gy per fraction once a day.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Melenda D. Jeter, MD, MPH · Assistant Professor, UT MDACC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-09
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00745732 on ClinicalTrials.gov