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Anti-metabolites

Paclitaxel TPM for Cancer

Phase 1

Recruiting

Led By Carlos Chan, MD, PhD

Research Sponsored by Carlos Chan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 an ECOG performance of 0 to 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial is testing a new cancer treatment in patients who are not eligible for standard-of-care treatments.

Who is the study for?

This trial is for adults aged 18-75 with peritoneal carcinomatosis from specific cancers, who can't have standard treatments. They must understand the study and agree to participate, have measurable disease, be medically fit for surgery, and use effective contraception. Exclusions include inaccessible abdominal cavity due to prior surgery, uncontrolled illnesses, pregnancy or breastfeeding women, certain infections like HIV/Hepatitis B/C on treatment.Check my eligibility

What is being tested?

The trial tests a new therapy using Paclitaxel-loaded microparticles designed to penetrate tumors in patients with peritoneal carcinomatosis. It's an early-phase study (phase I) focusing on people who don't qualify for existing treatment options.See study design

What are the potential side effects?

Potential side effects may include allergic reactions similar to those seen with paclitaxel (a chemotherapy drug), such as nerve damage (neuropathy), blood disorders, liver issues reflected by enzyme levels in blood tests and possibly other unknown risks since it's a first-in-human study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fit for surgery and can handle general anesthesia.

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I can take care of myself and am up and about more than half of my waking hours.

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I have no other standard treatment options left.

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I am using a barrier method of contraception.

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I have or am suspected to have cancer spread in my abdomen from colorectal, ovarian, gastric, pancreatic, appendiceal cancer, or mesothelioma.

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I am between 18 and 75 years old.

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I have not had my uterus or both ovaries removed.

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My abdominal cancer can be measured by scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

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

Assess whether intra-abdominal pressure is location-dependent

+2 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Neurotoxicity

13%

Alanine aminotransferase increased

13%

Cough

13%

Vomting

Headache

Musculoskeletal pain

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intraperitoneal paclitaxel-loaded tumor penetrating microparticles (TPM)Experimental Treatment1 Intervention

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.

0 / 8Eligibility criteria met