This phase II trial studies how well nab-paclitaxel and radiation therapy work in improving and maintaining ambulation in cancer patients with spinal cord compression. Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving nab-paclitaxel and radiation therapy may work better in treating epidural spinal cord compression in cancer patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03655080.
PRIMARY OBJECTIVES:
I. To assess ambulatory status at 1 month in patients with epidural spinal cord compression (ESCC) treated with pulsed nab-paclitaxel and radiotherapy.
SECONDARY OBJECTIVES:
I. To assess ambulatory status at 3 months, 6 months, 9 months, and 12 months in patients with ESCC treated with pulsed nab-paclitaxel and radiotherapy.
II. To assess strength of lower extremities at 1 month in patients with ESCC treated with pulsed nab-paclitaxel and radiotherapy.
III. To assess pain in the irradiated area in patients with ESCC treated with pulsed nab-paclitaxel and radiotherapy at 1 month, 3 months, 6 months, 9 months, and 12 months.
EXPLORATORY OBJECTIVES:
I. To determine the retreatment rate of patients with ESCC treated with pulsed nab-paclitaxel and radiotherapy.
II. To determine quality of life in patients with ESCC treated with pulsed nab-paclitaxel and radiotherapy at 1 month, 3 months, 6 months, 9 months, and 12 months.
III. To determine the walking index in patients with ESCC using the Walking Index for Spinal Cord Injury scale (WISCI II) in patients with ESCC treated with pulsed nab-paclitaxel and radiotherapy at 1 month, 3 months, 6 months, 9 months, and 12 months.
OUTLINE:
Patients receive nab-paclitaxel intravenously (IV) over 30 minutes on non-consecutive days for a total of 4 doses and undergo radiation therapy daily (Monday to Friday) for a total of 10 fractions in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month and every 3 months for up to 1 year.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorHiram Alberto Gay