Study on Intravenous and Abdominal Paclitaxel and Oral Nilotinib for Abdominal Cancer Spread from Various Primary Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05185947

Provider View

This clinical trial is testing a new treatment combining oral nilotinib with paclitaxel given both intravenously and directly into the abdomen to see if it can shrink tumors enough for surgery in adults with widespread abdominal cancer spread from various primary cancers.

Patient Parameters

Program Overview

This study is exploring a new treatment for peritoneal carcinomatosis, a condition where cancer has spread to the lining of the abdomen from other areas like the colon, appendix, or ovaries. The treatment combines oral nilotinib with paclitaxel, administered both intravenously and directly into the abdomen, to see if it can reduce tumors enough to allow for surgery. Participants will undergo several procedures, including laparoscopies, to place a port for drug administration and to monitor tumor response. The study involves treatment cycles and follow-up visits to assess the effectiveness and safety of the treatment.

Description

Peritoneal carcinomatosis is a serious condition where cancer spreads to the lining of the abdomen, often leading to poor outcomes. This study aims to test a new treatment approach using a combination of oral nilotinib and paclitaxel, given both intravenously and directly into the abdomen, to see if it can shrink tumors enough to make surgery possible.

Participants will be screened with various tests, including physical exams, blood tests, and imaging scans. They will undergo a procedure called laparoscopy, where small cuts are made in the abdomen to place a port for drug delivery and to take tissue samples.

The treatment will be given in cycles, with participants taking nilotinib by mouth twice daily and receiving paclitaxel through the port and intravenously. After certain cycles, participants will have additional laparoscopies and scans to check the treatment's progress. If the treatment is effective, participants may continue taking nilotinib and receiving paclitaxel for up to a year.

Follow-up visits will occur about six weeks after treatment ends and every three months for three years to monitor health and treatment effects.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with confirmed peritoneal carcinomatosis from cancers like colorectal, appendiceal, small bowel, gastric, cholangiocarcinoma, breast, ovarian, or other gynecologic origins.
  • Must have tried at least one approved chemotherapy treatment without success.
  • Must have measurable disease as defined by specific medical criteria.
  • Not eligible for surgery based on specific scoring criteria.
  • Must have good overall health with specific blood counts and organ function.
  • Women must agree to stop breastfeeding and use effective birth control during and after the study.
  • Must be able to understand and sign a consent form.
  • Must agree to participate in a related tissue collection study.

Exclusion Criteria

  • Currently taking or have recently taken other investigational drugs.
  • Have allergies to similar drugs used in the study.
  • Have had recent major abdominal surgery.
  • Have received certain chemotherapy or other cancer treatments recently.
  • Have uncontrolled illnesses or infections.
  • Pregnant individuals are not eligible.
  • Have certain heart conditions or are taking medications that affect heart rhythm.
  • Have a large amount of fluid in the abdomen or have had multiple fluid drainage procedures recently.
  • Have advanced liver disease or severe nerve damage.

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