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Sponsored by: |
Pharmacyclics |
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Information provided by: | Pharmacyclics |
ClinicalTrials.gov Identifier: | NCT00054795 |
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.
Condition | Intervention | Phase |
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Brain Neoplasms Carcinoma, Non-Small-Cell Lung Metastases, Neoplasm |
Drug: Motexafin Gadolinium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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;
Study ID Numbers: | PCYC-0211 |
Study First Received: | February 10, 2003 |
Last Updated: | May 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00054795 |
Health Authority: | United States: Food and Drug Administration |
Brain Neoplasms/radiotherapy Neoplasms/complications/prevention & control, Neuropsychological Tests, Metalloporphyrins/therapeutic use, Combined Modality Therapy, Drug therapy, Quality of Life, Cranial Irradiation, |
Radiotherapy/Targeted, Prospective Studies, Neoplasm Recurrence/Local, Treatment Outcome Brain metastases Brain Neoplasms/secondary Non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Disease Progression Quality of Life Central Nervous System Diseases Central Nervous System Neoplasms Motexafin gadolinium Brain Diseases Recurrence |
Carcinoma Brain Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis Carcinoma, Non-Small-Cell Lung Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Pharmacologic Actions Neoplasms |
Neoplastic Processes Photosensitizing Agents Neoplasms by Site Pathologic Processes Radiation-Sensitizing Agents Therapeutic Uses Dermatologic Agents |