Intraperitoneal Paclitaxel-loaded TPM for Treatment of Peritoneal Carcinomatosis

Inclusion Criteria:

• Ability to understand and the willingness to sign a written informed consentdocument

• Have pathology proven peritoneal carcinomatosis (PC) due to colorectal, ovarian,gastric, pancreatic, appendiceal cancer or mesothelioma, or suspected peritonealmetastasis based on radiological findings. (Patient to come off study if nopathology evidence of peritoneal metastasis at the time of surgery)

• No other standard treatment options are available

• Measurable intraperitoneal disease by RECIST v1.1 criteria , or by radiological PCIscoring when RECIST is not feasible, on imaging studies

• 18 to 75 years of age

• Have an ECOG performance of 0 to 2

• Have adequate organ and bone marrow functions as indicated by:

• Leukocytes ≥ 3000/mcL

• Absolute neutrophil count ≥ 1500/mcL

• Platelets ≥ 100000/mcL

• Total bilirubin within normal institutional limits

• AST (SGOT) < 3 x institutional upper limit of normal

• ALT (SPGT) < 3 x institutional upper limit of normal

• Medically fit for surgery. Defined as: Patients who are able to undergo generalanesthesia for abdominal surgery and have a metabolic equivalent (METs) ≥ 4

• Have adequate contraception, as follows:

1. Women of child-bearing potential and men with partners of child-bearingpotential must agree to use adequate contraception (hormonal or barrier methodof birth control; abstinence) prior to study entry, for the duration of studyparticipation, and for 10 months beyond the last dose of TPM. Should a womanbecome pregnant or suspect she is pregnant while participating in this study,she should inform her treating physician immediately

2. A woman of child-bearing potential is any female (regardless of sexualorientation, having undergone a tubal ligation, or remaining celibate bychoice) who meets the following criteria:

• has not undergone a hysterectomy or bilateral oophorectomy; or

• has not been naturally postmenopausal for at least 12 consecutive months (i.e., hashad menses at any time in the preceding 12 consecutive months) c. Men with partners of child bearing potential must use barrier contraceptive d. Men of child-bearing potential must not donate sperm while on this study and for 7 months after the last dose of TPM

Acceptable forms of birth control are listed below:

• One Barrier method (cervical cap with spermicide plus male condom; diaphragm withspermicide plus male condom) OR

• Hormonal method (oral contraceptives, implants, or injections) or an intrauterinedevice (e.g., Copper-T)

Exclusion Criteria:

• Presence of mucinous ascites

• Evidence of extra-peritoneal metastases

• Current or expected use of other investigational agents

• Received systemic chemotherapy or radiotherapy within 3 weeks prior to studyenrollment or not recovering from adverse events (e.g., recovery to ≤ Grade 1)

• Abdominal cavity deemed not accessible by treating surgeon due to prior abdominalsurgery

• History of allergic reactions to paclitaxel, PLG co-polymer, mannitol, orpolysorbate 80

• Uncontrolled intercurrent illness

• Currently active second malignancy other than non-melanoma skin cancer

• Pregnancy, nursing, or plans to become pregnant for the duration of studyparticipation including 10 months beyond the last dose of TPM

• Grade 2 or higher peripheral neuropathy

• CrCL ≤ 4 mL/min

• Actively treated for other malignancy

• Patients with HIV or Hepatitis B/C requiring the use of ART agents