Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Co… (NCT03655080) | Clinical Trial Compass
TerminatedPhase 2
Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression
Stopped: Pharmaceutical company decided to close study
United States2 participantsStarted 2019-01-09
Plain-language summary
The purpose of this research study is to look at a combination treatment of radiation therapy and a drug called Abraxane to treat epidural spinal cord compression.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with ≤ 37 points per the scoring system listed in the protocol
* Histologically or cytologically confirmed diagnosis of cancer not of CNS or spinal column origin.
* MRI or CT evidence of metastatic epidural spinal cord compression.
* Patients who have started 30 Gy in 10 fractions are not excluded as long as 4 doses of chemotherapy could potentially be given. This means the latest nab-paclitaxel can start is the morning of the third fraction of radiotherapy. Radiotherapy should ideally be delivered at least 6 hours after the nab-paclitaxel infusion started.
* At least 18 years of age.
* Normal bone marrow and organ function as defined below:
* Absolute neutrophil count ≥ 1,500 cells/mm3
* Platelets ≥ 100,000 cells/mm3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to blood draw)
* Hemoglobin \> 9.0 g/dL
* Total bilirubin ≤ 1.5 mg/dL
* AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
* Alkaline phosphatase ≤ 2.5 x IULN (unless bone metastasis is present (\< 5 x IULN) in the absence of liver metastasis)
* Creatinine ≤ 1.5 mg/dL
* Women of childbearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy or bilateral oophorectomy or (2) has not been naturally postmenopausal for at least 24 consecutive months) must:
* Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effect…