Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression

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,
effective contraception without interruption, 28 days prior to starting treatment
with nab-paclitaxel and while on study; and

- Have a negative serum pregnancy test result at screening and agree to ongoing
pregnancy testing during the course of the study and after the end of study
therapy. This applies even if the subject practices true abstinence from
heterosexual contact.

- Male subjects must practice true abstinence or agree to use a condom during sexual
contact with a pregnant female or a female of childbearing potential while
participating in the study, during dose interruptions, and for 6 months following
nab-paclitaxel discontinuation, even if he has undergone a successful vasectomy.

- Ability to understand and willingness to sign an IRB approved written informed consent
document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac
arrhythmia.

- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative
serum pregnancy test prior to study entry.

- Known HIV-positivity on combination antiretroviral therapy because of the potential
for pharmacokinetic interactions with nab-paclitaxel. In addition, these patients are
at increased risk of lethal infections when treated with marrow-suppressive therapy.
Appropriate studies will be undertaken in patients receiving combination
antiretroviral therapy when indicated.

- Previous spinal cord radiotherapy that would overlap with the proposed treatment
field.

- Spinal instability or bony retropulsion causing the cord compression. That is,
mechanical, not tumor, cord compression. In these cases surgery may be indicated.

- Patients eligible for surgical decompression like laminectomy.