Intraperitoneal Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Cancer of the Peritoneal Cavity

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of nab-paclitaxel as a
single agent administered intraperitoneally via an intraperitoneal catheter.

SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetics of nab-paclitaxel (Abraxane) in the
plasma and peritoneum when it is administered directly into the peritoneal cavity. II. To
determine the potential pharmacokinetic advantage (favorable ratio of nab-paclitaxel
(Abraxane) concentration in the peritoneal cavity vs. plasma) for nab-paclitaxel administered
intraperitoneally. III. To determine the progression of peripheral neuropathy in patients
treated with intraperitoneal chemotherapy on this study through pre-treatment and sequential
evaluation of the Neuropathic Pain Syndrome Inventory and Serial Nerve Conduction Studies.

OUTLINE: This is a dose-escalation study. Patients receive paclitaxel albumin-stabilized
nanoparticle formulation given intraperitoneally (IP) on days 1, 8, and 15. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Inclusion Criteria:

- Patients must have histological confirmed advanced cancer primarily confined to the
peritoneal cavity which have progressed on previous chemotherapeutic regimens, or for
which no "standard" chemotherapeutic regimens exist

- Prior taxane exposure is allowed; prior IP chemotherapy is allowed, if it was not
complicated by peritoneal adhesions; patients with ovarian cancer having residual
disease at second-look laparotomy or following secondary debulking are also eligible;
patients must be 4-6 weeks after surgery and they must have recovered from the surgery
prior to initiating IP chemotherapy

- Eastern Cooperative Oncology Group (ECOG) less than or equal to 2

- Life expectancy of greater than 3 months

- Absolute neutrophil count > 1,500/mcL

- Platelets > 100,000/mcL

- Total bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) <
2.5 x institutional upper limit of normal

- Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73
m^2 for patients with creatinine levels above institutional normal

- Documentation of measurable disease (with baseline measurements taken with 4 weeks of
study entry, when present and appropriate); presence of measurable disease is not, per
se, a prerequisite for entry onto this study

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation; should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administer more than 4 weeks earlier;
there is no limit on the number of prior lines of chemotherapy

- Patients may not be receiving any other investigational agents

- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse events

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to nab-paclitaxel

- Patients with ongoing abdominal infections or bowel obstruction

- Patients with known peritoneal adhesions that preclude the placement of an
intraperitoneal catheter in the opinion of the surgeon placing the intraperitoneal
catheter

- Pre-existing grade >= 2 sensory neuropathy

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with nab-paclitaxel

- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
therapy

- "Massive Ascites" requiring therapeutic paracentesis, will not be cause for
ineligibility, per se, it will be evaluated on an individual basis; investigators who
have any questions regarding assessing ascites are asked to speak with the Principal
Investigator