| Eligibility |
Inclusion Criteria:
- Documented informed consent of the participant and/or legally authorized
representative
- Patients must have histologically confirmed ovarian, uterine, gastric, appendiceal or
colorectal cancer with PC
- Prior IP chemotherapy is permitted
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
- Absolute neutrophil count (ANC) >= 1500/mm^3
- Platelets >= 100,000/mm^3
- Hemoglobin >= 9 g/dl
- Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) and
aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =<
2.5 x ULN, unless liver metastases (Arm 1) are present or unless patients is know to
have chronic liver disease (hepatitis) in which case AST and ALT must be =< 5 x ULN
- Alkaline phosphatase =< 2 x ULN
- Serum creatinine (sCr) =< 1.5 x ULN, or creatinine clearance (Ccr) >= 40 ml/min as
calculated by the Cockcroft-Gault formula
- No contraindications for a laparoscopy
- The peritoneal disease does not have to be measurable by RECIST 1.1 but needs to be
visible on cross sectional imaging or diagnostic laparoscopy
- Patients must have progressed on at least one evidence-based chemotherapeutic regimen
(Arm 1 and 2). For Arm 3, patients should have stable or responsive disease on at
least 4 months first-line systemic chemotherapy
- For patients with a known history of chronic hepatitis B virus (HBV) infection, the
HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a known history of hepatitis C virus (HCV) infection must have been
treated and cured. For patients with HCV infection who are currently on treatment,
they are eligible if they have an undetectable HCV viral load
- Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be
using an adequate method of contraception to avoid pregnancy throughout the study and
for up to 12 weeks after the last dose of investigational product in such a manner
that the risk of pregnancy is minimized. WOCBP include any female who has experienced
menarche and who has not undergone successful surgical sterilization (hysterectomy,
bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post
menopause is define as:
- Amenorrhea >= 12 consecutive months without another cause or
- For women with irregular menstrual periods and on hormone replacement therapy
(HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL
- Women who are using oral contraceptives, other hormonal contraceptives (vaginal
products, skin patches, or implanted or injectable products), or mechanical
products such as an intrauterine device or barrier methods (diaphragm, condoms,
spermicides) to prevent pregnancy, or are practicing abstinence or where their
partner is sterile (e.g., vasectomy) should be considered to be of childbearing
potential
- INCLUSION TO PROCEED WITH PIPAC: Laparoscopy findings must meet all of the below
criteria in order to proceed to PIPAC:
- PIPAC access is feasible
- There is room for aerosol therapy
- There is no evidence of impending bowel obstruction
- =< 5 L of ascites
- Not a candidate for cytoreduction and HIPEC
Exclusion Criteria:
- Gastric and colorectal/appendiceal:
- Extra-peritoneal metastatic disease
- Arm 1 (ovarian, uterine, gastric): Previous treatment with maximum cumulative doses of
doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and
anthracenediones
- Arm 2 (colorectal/appendiceal): Known dihydropyrimidine dehydrogenase deficiency (DPD)
deficiency
- Arm 2 (colorectal/appendiceal): Bowel obstruction requiring nasogastric tube,
percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition
- Arm 2 (colorectal/appendiceal): Prior unanticipated severe reaction or
hypersensitivity to platinum based compounds
- Arm 2 (colorectal/appendiceal): Patients who have not recovered from adverse events
due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1), with the
exception of alopecia, hearing loss, or non-clinically significant laboratory
abnormalities. Grade 2 peripheral neuropathy is permitted
- Arm 2 (colorectal/appendiceal): Life expectancy of less than 6 months
- Arm 2 (colorectal/appendiceal): Chemotherapy or surgery within the last 4 weeks prior
to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other
anti-cancer agents
- Arm 2 (colorectal/appendiceal): Previous anaphylactic reaction to the chemotherapy
drug used
- Arm 2 (colorectal/appendiceal): Patients may not be receiving any other
investigational or concurrent anti-cancer agents
- Arm 2 (colorectal/appendiceal): Ascites due to decompensated liver cirrhosis; portal
vein thrombosis
- Arm 2 (colorectal/appendiceal): Simultaneous tumor debulking with gastrointestinal
resection
- Arm 2 (colorectal/appendiceal): Uncontrolled intercurrent illness including, but not
limited to ongoing or active infection, symptomatic congestive heart failure, severe
myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe
renal impairment, myelosuppression, or severe hepatic impairment
- Arm 2 (colorectal/appendiceal): Immunocompromised patients such as those with an
immunosuppressive medication or a known disease of the immune system
- Arm 2 (colorectal/appendiceal): Involvement in the planning and conduct of the study
- Arm 2 (colorectal/appendiceal): Pregnancy
- Arm 2 (colorectal/appendiceal): Patients with psychiatric illness/social situations
that would limit compliance with study requirements
- Arm 2 (colorectal/appendiceal): New York Heart Association (NYHA) class 3 or 4;
myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or
chronic obstructive pulmonary disease (COPD) requiring hospitalization in the
preceding 6 months
- Arm 2 (colorectal/appendiceal): Major systemic infection requiring antibiotics 72
hours or less prior to the first dose of study drug
- Arm 2 (colorectal/appendiceal): Exclusive total parenteral nutrition
- Arm 2 (colorectal/appendiceal): Prior intra-abdominal aerosol chemotherapy
- Arm 3 (colorectal/appendiceal): Progression on first- AND second-line systemic therapy
- Arm 3 (colorectal/appendiceal): Hematologic toxicities requiring significant dose
reductions while on systemic chemotherapy
- Arm 3 (colorectal/appendiceal): Intolerance to prior 5-FU at 2400mg/m^2 IV every 2
weeks or to irinotecan at 180mg/m^2. Intolerance is defined as the need of significant
dose reduction or treatment interruption of > 1 week due to toxicity
- Arm 3 (colorectal/appendiceal): Known DPD deficiency
- Arm 3 (colorectal/appendiceal): Bowel obstruction requiring nasogastric tube,
percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition
- Arm 3 (colorectal/appendiceal): Patients who have not recovered from adverse events
due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1), with the
exception of alopecia, hearing loss, or non-clinically significant laboratory
abnormalities. Grade 2 peripheral neuropathy is permitted
- Arm 3 (colorectal/appendiceal): Life expectancy of less than 6 months
- Arm 3 (colorectal/appendiceal): Chemotherapy or surgery within the last 2 weeks prior
to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other
anti-cancer agents
- Arm 3 (colorectal/appendiceal): Previous anaphylactic reaction to the chemotherapy
drug used
- Arm 3 (colorectal/appendiceal): Patients may not be receiving any other
investigational anti-cancer agents
- Arm 3 (colorectal/appendiceal): Ascites due to decompensated liver cirrhosis; portal
vein thrombosis
- Arm 3 (colorectal/appendiceal): Simultaneous tumor debulking with gastrointestinal
resection
- Arm 3 (colorectal/appendiceal): Uncontrolled intercurrent illness including, but not
limited to ongoing or active infection, symptomatic congestive heart failure, severe
myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe
renal impairment, myelosuppression, or severe hepatic impairment
- Arm 3 (colorectal/appendiceal): Immunocompromised patients such as those with an
immunosuppressive medication or a known disease of the immune system
- Arm 3 (colorectal/appendiceal): Involvement in the planning and conduct of the study
- Arm 3 (colorectal/appendiceal): Pregnancy
- Arm 3 (colorectal/appendiceal): Patients with psychiatric illness/social situations
that would limit compliance with study requirements
- Arm 3 (colorectal/appendiceal): New York Heart Association (NYHA) class 3 or 4;
myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or
chronic obstructive pulmonary disease (COPD) requiring hospitalization in the
preceding 6 months
- Arm 3 (colorectal/appendiceal): Major systemic infection requiring antibiotics 72
hours or less prior to the first dose of study drug
- Arm 3 (colorectal/appendiceal): Exclusive total parenteral nutrition
- Arm 3 (colorectal/appendiceal): Prior intra-abdominal aerosol chemotherapy
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