Intraperitoneal Paclitaxel-loaded TPM for Treatment of Peritoneal Carcinomatosis

Launched by CARLOS CHAN · Dec 1, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with peritoneal carcinomatosis, a condition where cancer spreads to the lining of the abdominal cavity. The treatment being studied involves using tiny particles filled with a medication called Paclitaxel, which is designed to penetrate and target tumors directly. This trial is for adults aged 18 to 75 who have been diagnosed with peritoneal carcinomatosis from specific types of cancer, such as colorectal or ovarian cancer, and who do not have any other standard treatment options available. Participants must be able to understand the study and sign a consent form.

If you or a loved one is eligible and chooses to participate, you can expect to receive this experimental treatment during surgery. The trial is currently recruiting participants, and it aims to assess the safety and effectiveness of the Paclitaxel-loaded particles. It's important to note that certain criteria, such as having adequate organ function and no other active cancers, must be met to join the study. Participants will also need to use effective birth control methods throughout the study duration and for several months afterward.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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
• * 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:
• • 1. 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
• 2. 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)
• • c. Men with partners of child bearing potential must use barrier contraceptive
• • d. 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)
• Exclusion Criteria:
• • 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