PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer

Conditions

• Clinical Stage IV Gastric Cancer AJCC v8
• Clinical Stage IVA Gastric Cancer AJCC v8
• Clinical Stage IVB Gastric Cancer AJCC v8
• Malignant Uterine Neoplasm
• Metastatic Appendix Carcinoma
• Metastatic Colorectal Carcinoma
• Metastatic Gastric Carcinoma
• Metastatic Malignant Neoplasm in the Peritoneum
• Metastatic Malignant Solid Neoplasm
• Metastatic Ovarian Carcinoma
• Pathologic Stage IV Gastric Cancer AJCC v8
• Peritoneal Carcinomatosis
• Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8
• Stage IV Appendix Carcinoma AJCC v8
• Stage IV Colorectal Cancer AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IV Uterine Corpus Cancer AJCC v8
• Stage IVA Appendix Carcinoma AJCC v8
• Stage IVA Colorectal Cancer AJCC v8
• Stage IVA Ovarian Cancer AJCC v8
• Stage IVA Uterine Corpus Cancer AJCC v8
• Stage IVB Appendix Carcinoma AJCC v8
• Stage IVB Colorectal Cancer AJCC v8
• Stage IVB Ovarian Cancer AJCC v8
• Stage IVB Uterine Corpus Cancer AJCC v8
• Stage IVC Appendix Carcinoma AJCC v8
• Stage IVC Colorectal Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy — PROCEDURE
  Undergo biopsy
• Cisplatin — DRUG
  Given via PIPAC
• Doxorubicin — DRUG
  Given via PIPAC
• Fluorouracil — DRUG
  Given IV
• Intraperitoneal Chemotherapy — DEVICE
  Undergo PIPAC
• Irinotecan — DRUG
  Given IV
• Leucovorin — DRUG
  Given IV
• Mitomycin — DRUG
  Given via PIPAC
• Oxaliplatin — DRUG
  Given via PIPAC
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

This phase I trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Chemotherapy drugs, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, fluorouracil, mitomycin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PIPAC is a minimally invasive procedure that involves the administration of intraperitoneal chemotherapy. The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and/or to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.

Key Dates

Start date

Aug 21, 2020

Status verified

Dec 2025

Primary completion

Jan 5, 2028

Completion

Jan 5, 2028

Study Design

Enrollment

49 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (PIPAC, doxorubicin, cisplatin) - Not recruiting
  Patients with ovarian, uterine, or gastric cancer, undergo PIPAC with doxorubicin IP, followed by cisplatin IP. Treatment repeats every 4-6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II (PIPAC, oxaliplatin, leucovorin, fluorouracil) - Not recruiting
  Patients with colorectal or appendiceal cancer undergo PIPAC with oxaliplatin IP. For cycles 2 and 3, patients receive leucovorin IV over 10 minutes and fluorouracil IV over 15 minutes 1-24 hours before undergoing PIPAC. Treatment repeats every 4-6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm III (PIPAC, mitomycin, FOLFIRI) - Not recruiting
  Patients with colorectal or appendiceal cancer who have undergo at least 4 months (or 8 cycles) of first-line standard of care chemotherapy but have not progressed on second line chemotherapy undergo PIPAC with mitomycin IP. Patients also receive standard of care irinotecan IV over 90 on day 1, leucovorin IV over 30 minutes on day 1, and fluorouracil IV on days 1-2 during weeks 2, 4, 8, 10, 14 and 16. Treatment repeats every 4-6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm IV (PIPAC, Cisplatin and nab-paclitaxel)
  Patients with recurrent ovarian cancer ( platinum-resistent or platinum metastases) patients with unresectable peritoneal metastases who are not candidates for cytoreductive surgery, at least 6 months after completion of first-line standard of care chemotherapy, and no bowel obstruction. Treatment for each 28-day cycle will consist of PIPAC with cisplatin (15 mg/m2) and nab-paclitaxel (90 mg/m2) on D1 every 28 days. A dose de-escalation plan is provided if the starting dose is not well-tolerated.

Primary Outcome Measure

Dose limiting toxicities [ Time Frame: Up to 18 weeks ]

Locations (3)

Find similar trials in Duarte, CA

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