Peritoneal CarcinomatosisPhase 1NCT05159050
Intraperitoneal Paclitaxel-loaded TPM for Treatment of Peritoneal Carcinomatosis
A Phase 1 study testing Paclitaxel-loaded tumor penetrating microparticles in people with Peritoneal Carcinomatosis, run by Carlos Chan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- Paclitaxel-loaded tumor penetrating microparticles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2022to 9 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 18 to 75 years of age
- Have an ECOG performance of 0 to 2
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- 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:
- Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 10 months beyond the last dose of TPM. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) 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., has had menses at any time in the preceding 12 consecutive months)
- Men with partners of child bearing potential must use barrier contraceptive
- 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 with spermicide plus male condom) OR
- Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
About this study
Official title: Phase I Trial of Intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM) for Treatment of Peritoneal Carcinomatosis
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.
Read the detailed description
This is a first in human study of Paclitaxel-loaded TPM, suspended in 0.5 L of 0.1% polysorbate 80 in normal saline instilled into the peritoneal cavity.
An enrolled patient will (a) undergo laparoscopy during which time the hydrostatic pressures at different locations within the peritoneal cavity are measured, pretreatment tumors are biopsied and peritoneal catheter is placed, (b) receive intraperitoneal TPM during index hospital stay, and (c) followed-up to evaluate treatment-related toxicity and response. The pharmacokinetics of TPM and paclitaxel in peritoneal fluid and systemic blood samples will be measured. Second dose of TPM is given in clinic if no disease progression or significant AEs.
This is a dose escalation study. Dose escalation will proceed using an accelerated titration design (ATD) with intra-patient dose escalation.
In the event either:
- 1 patient exhibits DLT during the first course of treatment or
- 2 patients exhibit grade 2 study drug-related (attribution of probable or definite) toxicity during the first course of treatment.
The design switches to a standard 3+3 design at the dose that triggered the switch-two additional patients are accrued at this dose level. Decisions on when and how to escalate if the design switches to a 3+3 are described in the protocol section 6.3
- Conditions
- Peritoneal Carcinomatosis
- Being tested
- Paclitaxel-loaded tumor penetrating microparticles
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-loaded tumor penetrating microparticlesDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Paclitaxel-loaded tumor penetrating microparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 Weeks
Secondary outcomes (5)
Assess potential therapeutic efficacy of intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM)
Tumor response will be measured by RECIST v1.1 to determine potential effective doses of intraperitoneal Paclitaxel-loaded TPM.
Measured: 12 Weeks
Measure area-under-drug concentration-time curve of Paclitaxel and tumor penetrating microparticles (TPM) in blood and peritoneal fluid
Paclitaxel-loaded TPM pharmacokinetics will be described using summary statistics, such as mean and range, and graphical displays.
Measured: 8 Weeks
Measure maximum drug concentration of Paclitaxel and tumor penetrating microparticles (TPM) in blood and peritoneal fluid
Paclitaxel-loaded TPM pharmacokinetics will be described using summary statistics, such as mean and range, and graphical displays.
Measured: 8 Weeks
Assess whether Paclitaxel-loaded Tumor Penetrating Microparticles (TPM) induce immune response in the peritoneal cavity
The presence or absence of T cell infiltration in peritoneal cavity.
Measured: 8 Weeks
Assess whether intra-abdominal pressure is location-dependent
Intra-abdominal hydrostatic pressures at various intraperitoneal locations will be measured at the time of laparoscopy
Measured: Day 1 on study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start26 Apr 2022
- Primary completion17 Mar 2024
- Study completion9 Dec 2025
Why it stopped: Drug supply issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carlos Chan
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Quantitative Systems Pharmacology (IQSP)
- Responsible party
- Sponsor-investigator, Carlos Chan, University of Iowa
- Investigators
- Carlos Chan, MD, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159050
- Sponsor's protocol ID
- 202105008
- Status last verified
- Feb 2026
- First submitted
- 8 Nov 2021
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM) for Treatment of Peritoneal Carcinomatosis
- ClinicalTrials.gov ID
- NCT05159050
- Acronym / sponsor ID
- 202105008
- Conditions
- Peritoneal Carcinomatosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug supply issues
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Carlos ChanUniversity, hospital or other
- Collaborators
- Institute of Quantitative Systems Pharmacology (IQSP)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 17 Mar 2024 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a first in human study of Paclitaxel-loaded TPM, suspended in 0.5 L of 0.1% polysorbate 80 in normal saline instilled into the peritoneal cavity.
An enrolled patient will (a) undergo laparoscopy during which time the hydrostatic pressures at different locations within the peritoneal cavity are measured, pretreatment tumors are biopsied and peritoneal catheter is placed, (b) receive intraperitoneal TPM during index hospital stay, and (c) followed-up to evaluate treatment-related toxicity and response. The pharmacokinetics of TPM and paclitaxel in peritoneal fluid and systemic blood samples will be measured. Second dose of TPM is given in clinic if no disease progression or significant AEs.
This is a dose escalation study. Dose escalation will proceed using an accelerated titration design (ATD) with intra-patient dose escalation.
In the event either:
- 1 patient exhibits DLT during the first course of treatment or
- 2 patients exhibit grade 2 study drug-related (attribution of probable or definite) toxicity during the first course of treatment.
The design switches to a standard 3+3 design at the dose that triggered the switch-two additional patients are accrued at this dose level. Decisions on when and how to escalate if the design switches to a 3+3 are described in the protocol section 6.3
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal paclitaxel-loaded tumor penetrating microparticles (TPM) | Experimental | Drug: Paclitaxel-loaded tumor penetrating microparticlesPaclitaxel-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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
- 18 to 75 years of age
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel-loaded tumor penetrating microparticlesPaclitaxel-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 | Drug | Intraperitoneal paclitaxel-loaded tumor penetrating microparticles (TPM) |
Primary outcome
Assess safety of intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM)
Time frame: 12 Weeks
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.
Determine the maximum tolerated dose (MTD) of intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM)
Time frame: 4 Weeks
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.
5 secondary outcomes
Assess potential therapeutic efficacy of intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM)
Time frame: 12 Weeks
Measure area-under-drug concentration-time curve of Paclitaxel and tumor penetrating microparticles (TPM) in blood and peritoneal fluid
Time frame: 8 Weeks
Measure maximum drug concentration of Paclitaxel and tumor penetrating microparticles (TPM) in blood and peritoneal fluid
Time frame: 8 Weeks
Assess whether Paclitaxel-loaded Tumor Penetrating Microparticles (TPM) induce immune response in the peritoneal cavity
Time frame: 8 Weeks
Assess whether intra-abdominal pressure is location-dependent
Time frame: Day 1 on study
Results and safety
The study was stopped early (reason given: Drug supply issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Chan, MD, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paclitaxel-loaded tumor penetrating microparticles in people with Peritoneal Carcinomatosis, run by Carlos Chan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Drug supply issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess safety of intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM) (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.