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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Metastases, Neoplasm
Both
Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Metastases, Neoplasm
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
PCYC-0211
NCT ID:
NCT00054795
Start Date:
Completion Date:
Related Keywords:
- Brain Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Metastases, Neoplasm
- 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
- Brain Neoplasms
- Neoplasms
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Neoplasm Metastasis
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Alexandria, Minnesota 56308 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Flint, Michigan 48532 | |
| McLean, Virginia 22101 | |
| Little Rock, Arkansas 72205-7199 | |
| Omaha, Nebraska 68114 | |
| Hackensack, New Jersey 07601 | |
| Albuquerque, New Mexico 87131-5636 | |
| Metairie, Louisiana 70006 | |
| Denver, Colorado | |
| Baltimore, Maryland 21287 | |
| Boston, Massachusetts | |
| Milwaukee, Wisconsin | |
| Indianapolis, Indiana |
