Treatment of colorectal cancer that has spread to the peritoneum using intraperitoneal chemotherapy
A Phase I Study of Intraperitoneal 5FU+Oxaliplatin in Patients With Colorectal Cancer With Isolated Peritoneal Metastasis
This study is testing a new way to treat colorectal cancer that has spread to the abdomen by giving chemotherapy directly into the belly to see how safe it is and what the best dose is.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Columbus, Ohio and 1 other locations) |
| Trial ID | NCT06269978 on ClinicalTrials.gov |
What this trial studies
This phase I trial evaluates the safety, side effects, and optimal dosing of intraperitoneal oxaliplatin and fluorouracil in patients with colorectal cancer that has metastasized to the peritoneal cavity. The study involves a dose-escalation approach where patients receive these medications directly into the peritoneal space, which may enhance their effectiveness. Participants will undergo various assessments including diagnostic laparoscopy, imaging, and blood sample collection to monitor treatment response and safety. The trial aims to determine the maximum tolerated dose and the pharmacokinetics of the drugs in both blood and peritoneal fluid.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven colorectal cancer and peritoneal metastasis, who have not previously undergone certain surgical treatments.
Not a fit: Patients with extraperitoneal metastases or those who have undergone cytoreductive surgery and HIPEC for colorectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with peritoneal metastases from colorectal cancer.
How similar studies have performed: While the use of intraperitoneal chemotherapy is an established approach, this specific combination and method is experimental and has not been widely tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 18 years * Biopsy proven colorectal cancer with peritoneal metastasis. Patients with extraperitoneal metastases will not be eligible. Patients with involvement of intra-abdominal lymph nodes may be eligible at the discretion of the treating physician * Primary colorectal cancer may either be left in place or have been resected prior to study enrollment * Patients are allowed to have received prior colorectal cancer-directed systemic therapy. * Not previously undergone cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at the time of enrollment * Absolute neutrophil count (ANC) ≥ 1,500 /mcL * Platelets ≥ 100,000 / mcL * Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60 mL/min for patient with creatinine levels \> 1.5 x institutional ULN (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) * Creatinine clearance should be calculated per institutional standard * Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patient with total bilirubin levels \> 1.5 ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN * Both values must be in the specified range * Albumin \>= 2.5 g/dL * International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants * Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants * Patients on anticoagulation or antiplatelet agents may be enrolled at the discretion of the treating physician, provided these can be safely held as needed for surgical procedures * Anticipated life expectancy of ≥ 6 months * Willing to comply with study procedures * Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study and at least 9 months after the last dose of study medication * For female patients of childbearing potential, a negative pregnancy test is required at or within 7 days prior to enrollment * Be willing and able to understand and sign the written informed consent document * Be willing to undergo two diagnostic laparoscopies with tumor biopsy tissue. Patients must consent to on-treatment biopsies prior to initiation of clinical trial * Be willing to provide peripheral blood and peritoneal samples for correlative studies Exclusion Criteria: * Patients who are receiving any other investigational drugs * Evidence of metastatic disease other than peritoneum based on standard of care (SOC) imaging * Patients with primary mucinous appendiceal tumors will not be eligible. These tumors often produce mucin, which may affect the penetration of IP chemotherapy. Patients with non-mucinous appendiceal adenocarcinomas will be eligible. * Patients with \>= grade 2 peripheral neuropathy * Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, active bleeding diatheses, and psychiatric illness/social situations that would limit compliance with study requirements * Major surgical procedure or significant traumatic injury less than 3 weeks or those who receive minor surgical procedures within 1 week from first dose of study drug administration * Known active chronic infections - uncontrolled human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), known active (i.e., with detectable polymerase chain reaction \[PCR\]) hepatitis B or C * Cirrhosis (Child-Pugh B or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis * Pregnancy or breastfeeding * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating physician
Where this trial is running
Columbus, Ohio and 1 other locations
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
- UT Southwestern/Simmons Cancer Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Arjun Mittra, MD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.