Intraperitoneal Paclitaxel-loaded TPM for Treatment of Peritoneal Carcinomatosis

NCT05159050 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 202105008
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

A first-in-human, unblinded, phase I trial of Paclitaxel-loaded tumor penetrating microparticles (TPM) in peritoneal carcinomatosis patients who are not eligible for standard-of-care therapeutic interventions.

Conditions

Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (2)

• Assess safety of intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM)

  The incidence of treatment-emergent adverse events will be summarized by system organ class and/or preferred term, type of adverse event, severity (based on NCI CTCAE v5.0 grades), and relation to study treatment using the safety population.

  12 Weeks

• Determine the maximum tolerated dose (MTD) of intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM)

  Dose escalation will proceed using an accelerated titration design (ATD). Subjects will be observed for 4 weeks after the first course of TPM treatment for any potential dose limiting toxicities (DLT). The MTD is defined as the highest dose level for which at most 1 out of 6 patients experience a DLT.

  4 Weeks

Secondary Outcomes (5)

• Assess potential therapeutic efficacy of intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM)

  12 Weeks

• Measure area-under-drug concentration-time curve of Paclitaxel and tumor penetrating microparticles (TPM) in blood and peritoneal fluid

  8 Weeks

• Measure maximum drug concentration of Paclitaxel and tumor penetrating microparticles (TPM) in blood and peritoneal fluid

  8 Weeks

• Assess whether Paclitaxel-loaded Tumor Penetrating Microparticles (TPM) induce immune response in the peritoneal cavity

  8 Weeks

• Assess whether intra-abdominal pressure is location-dependent

  Day 1 on study

Study Arms (1)

Intraperitoneal paclitaxel-loaded tumor penetrating microparticles (TPM)

EXPERIMENTAL

Paclitaxel-loaded tumor penetrating microparticles (TPM), dose escalation starting at 50 mg/m\^2 instilled in the peritoneal cavity at study start and again 6-8 weeks after the first TPM treatment.

Drug: Paclitaxel-loaded tumor penetrating microparticles

Interventions

Paclitaxel-loaded tumor penetrating microparticles DRUG

Paclitaxel-loaded TPM, suspended in 0.5 L of 0.1% (w/v) polysorbate 80 in 0.9% sodium chloride is instilled into the peritoneal cavity over 3 to 5 minutes. Mixing of TPM is achieved by putting patient in 5 different positions for about 80 minutes. Dose escalation, the starting dose of TPM is 50 mg/m\^2 paclitaxel-equivalents. Dose escalation will follow the Accelerated Titration Design. The dose levels to which patients will be assigned in sequential cohorts are listed below. Dose escalation schedule of TPM, Dose Level 1\*: 50 mg/m\^2; Dose Level 2: 100 mg/m\^2; Dose Level 3: 135 mg/m\^2; Dose Level 4: 175 mg/m\^2; Dose Level 5: 200 mg/m\^2 \*Starting Dose

Intraperitoneal paclitaxel-loaded tumor penetrating microparticles (TPM)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document
• Have pathology proven peritoneal carcinomatosis (PC) due to colorectal, ovarian, gastric, pancreatic, appendiceal cancer or mesothelioma, or suspected peritoneal metastasis based on radiological findings. (Patient to come off study if no pathology 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 PCI scoring when RECIST is not feasible, on imaging studies
• 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 general anesthesia for abdominal surgery and have a metabolic equivalent (METs) ≥ 4
• Have adequate contraception, as follows:

You may not qualify if:

• 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 study enrollment or not recovering from adverse events (e.g., recovery to ≤ Grade 1)
• Abdominal cavity deemed not accessible by treating surgeon due to prior abdominal surgery
• History of allergic reactions to paclitaxel, PLG co-polymer, mannitol, or polysorbate 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 study participation 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

Sponsors & Collaborators

• Carlos Chan: lead
• Institute of Quantitative Systems Pharmacology (IQSP): collaborator

Study Sites (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Study Officials

• Carlos Chan, MD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 15, 2021
• Study Start: April 26, 2022
• Primary Completion: March 17, 2024
• Study Completion: December 9, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)