Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Clinical Stage IVA Gastric Cancer AJCC v8
  • Appendiceal Cancer
  • Stage IVB Ovarian Cancer AJCC v8
  • Clinical Stage IV Gastric Cancer AJCC v8
  • Clinical Stage IVB Gastric Cancer AJCC v8
  • Stage IVB Colorectal Cancer AJCC v8
  • Stage IIIB Ovarian Cancer
  • Stage IIIC Ovarian Cancer
  • Malignant Uterine Neoplasm
  • Metastatic Colorectal Carcinoma
  • Stage IVA Colorectal Cancer AJCC v8
  • Metastatic Gastric Carcinoma
  • Metastatic Malignant Neoplasm in the Peritoneum
  • Stage IIIB Endometrial Cancer
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IIIA Ovarian Cancer
  • Metastatic Ovarian Carcinoma
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IVA Ovarian Cancer AJCC v8
  • Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8
  • Stage IIIC Endometrial Cancer
  • Stage IV Uterine Corpus Cancer AJCC v8
  • Pathologic Stage IV Gastric Cancer AJCC v8
  • Stage IVA Uterine Corpus Cancer AJCC v8
  • Stage IVB Uterine Corpus Cancer AJCC v8
  • Stage IIIA Endometrial Cancer
  • Stage IVC Colorectal Cancer AJCC v8
  • Peritoneal Carcinomatosis
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVE: I. To evaluate the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in 2 groups of patients with peritoneal carcinomatosis (PC), either due to primary ovarian, uterine, appendiceal, or gastric carcinoma (Arm 1) or to primary colorectal carcinoma (Arm 2), based on...

PRIMARY OBJECTIVE: I. To evaluate the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in 2 groups of patients with peritoneal carcinomatosis (PC), either due to primary ovarian, uterine, appendiceal, or gastric carcinoma (Arm 1) or to primary colorectal carcinoma (Arm 2), based on treatment-related adverse events reported by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. SECONDARY OBJECTIVES: I. Efficacy will be assessed by: Ia. Response Evaluation Criteria in Solid Tumors (RECIST), if available, version 1.1 via computed tomography (CT) scan at baseline, following the second cycle (week 10), and 6 weeks after completing treatment (at 18 weeks/off study). Ib. Peritoneal regression grading score (PRGS) via biopsy at each cycle (both preoperative and postoperative peritoneal samples will be obtained). Ic. Peritoneal carcinomatosis index (PCI) at the time of laparoscopy. II. Post-operative surgical complications by Claven-Dindo classification evaluated at 4, 10, and 16 weeks (4 weeks after each PIPAC). III. Progression-free survival. IV. PIPAC technical failure rate. V. Patient-reported health state/quality of life and symptoms before treatment and at 6, 12, and 18 weeks/off study, as measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L) and MD Anderson Symptom Inventory (MDASI). VI. Functional status, as measured by the number of daily steps before and after treatments (Vivofit 4 wristband pedometer - Garmin Company). EXPLORATORY OBJECTIVE: I. Correlative/translational studies to characterize the tumor microenvironment, subclonal evolution, genomics, and pharmacokinetics of peritoneal tumors. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients with ovarian, uterine, appendiceal or gastric cancer, undergo PIPAC with cisplatin, followed by doxorubicin. Treatment repeats every 6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. ARM II: Patients with colorectal cancer undergo PIPAC with oxaliplatin. For cycles 2 and 3, patients receive leucovorin intravenously (IV) over 10 minutes and fluorouracil IV over 15 minutes 1-24 hours before undergoing PIPAC. Treatment repeats every 6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks for up to 3 years.

Tracking Information

NCT #
NCT04329494
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Thanh H Dellinger City of Hope Medical Center Principal Investigator: Mustafa Raoof, MD City of Hope Medical Center