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Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)
This study has been completed.
Study NCT00054795   Information provided by Pharmacyclics
First Received: February 10, 2003   Last Updated: May 4, 2007   History of Changes

February 10, 2003
May 4, 2007
 
 
 
 
Complete list of historical versions of study NCT00054795 on ClinicalTrials.gov Archive Site
 
 
 
Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)
Randomized Phase III Trial of Xcytrin® (Motexafin Gadolinium) Injection for the Treatment of Brain Metastases in Patients With Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation Therapy

The primary purpose of the study is to determine if patients with brain metastases from non-small cell lung cancer treated with Motexafin Gadolinium and whole brain radiation therapy retain their neurologic function and ability to think for a longer time compared to patients treated with whole brain radiation therapy alone.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
  • Brain Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Metastases, Neoplasm
Drug: Motexafin Gadolinium
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
550
 
 

Inclusion Criteria:

  • Adults (≥18 years old) with radiologically proven parenchymal brain metastases from histologically confirmed non-small cell lung cancer;
  • KPS score of ≥70;
  • Each patient must sign a study-specific Informed Consent form

Exclusion Criteria:

  • Liver metastases;
  • Extracranial metastases in two or more organs;
  • Known leptomeningeal metastases or subarachnoid spread of tumor;
  • Prior whole brain radiation;
  • Plan to use radiosurgery or radiation boost after completion of WBRT;
  • Planned chemotherapy during study treatment (prior and subsequent chemotherapy is allowed);
  • Prior total resection of a single brain metastasis;
  • Laboratory values as follows:

LDH > 1.3 x upper limit of normal (ULN); ANC < 1500 /mm³; Platelets < 50,000 /mm³; Creatinine > 2.0 mg/dL; AST or ALT > 2 x ULN; Total bilirubin > 2 x ULN;

  • Women who are pregnant or lactating
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Netherlands
 
NCT00054795
 
PCYC-0211
Pharmacyclics
 
 
Pharmacyclics
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP