Metastatic Colorectal CarcinomaPhase 1NCT06269978
Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer
A Phase 1 study testing Biopsy, Biospecimen Collection and Computed Tomography in people with Metastatic Colorectal Carcinoma and Metastatic Malignant Neoplasm in the Peritoneum, run by Arjun Mittra at 2 sites in United States.
Trial summary
This phase I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Peritoneum, Stage IV Colorectal Cancer AJCC v8
- What is being tested?
- Biopsy, Biospecimen Collection and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Dec 2024to 30 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
UT Southwestern/Simmons Cancer Center
Dallas, Texas, 75390
About this study
Official title: A Phase I Study of Intraperitoneal 5FU+Oxaliplatin in Patients With Colorectal Cancer With Isolated Peritoneal Metastasis
This phase I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Fluorouracil stops cells from making DNA and it may kill cancer cells. Both oxaliplatin and fluorouracil are approved by the Food and Drug Administration to treat patients with colorectal cancer, however administration of these drugs directly into the area between the muscles and organs in the abdomen (intraperitoneal) for the treatment of peritoneal metastases is experimental. Giving oxaliplatin and fluorouracil directly into the peritoneal space may be a safe and effective way of treating patients with peritoneal metastases from colorectal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine safety, tolerability, and maximally tolerated dose (MTD) of intraperitoneal (IP) fluorouracil (5FU)+oxaliplatin.
II. Determine pharmacokinetics (PK) of IP 5FU+oxaliplatin both in blood and peritoneal fluid.
SECONDARY OBJECTIVES:
- Determine tumor-cell intrinsic effects, modulation of the tumor immune microenvironment, and changes in the makeup of circulating immune cells in response to IP 5FU+oxaliplatin.
II. Identify preliminary response from IP 5FU+oxaliplatin: assess the rate of conversion from unresectable to resectable (determined by peritoneal carcinomatosis index [PCI] decreasing to < 20) and response rates by imaging criteria.
OUTLINE: This is a dose-escalation study of 5FU and oxaliplatin followed by a dose-expansion study.
Patients undergo placement of indwelling IP port for chemotherapy infusion. Patients receive oxaliplatin and 5FU over 1-2 hours via IP infusion on days 1 and 15 of each cycle. Cycles repeat every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo diagnostic laparoscopy, biopsy, computed tomography (CT)/magnetic resonance imaging (MRI), and collection of blood samples at screening and on study and undergo collection of IP fluid samples on study.
After completion of study treatment, patients are followed up for 30 days. Patients with confirmed disease progression or who start a new anti-cancer therapy are followed up every 12 weeks until death, withdrawal of consent, or end of study.
- Conditions
- Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Peritoneum, Stage IV Colorectal Cancer AJCC v8
- Being tested
- Biopsy, Biospecimen Collection, Computed Tomography, Diagnostic Laparoscopy, Fluorouracil
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood and IP fluid samples
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Diagnostic LaparoscopyProcedure or surgery
Undergo diagnostic laparoscopy
FluorouracilDrug
Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
Given via IP infusion
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Undergo MRI
OxaliplatinDrug
Also called 1-OHP, Ai Heng, Aiheng, Dacotin
Given via IP infusion
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgery Type, Surgery, NOS
Undergo placement of indwelling IP port
| Study group | Role | What they receive |
|---|---|---|
| Treatment (oxaliplatin, 5FU) | Experimental | Patients undergo placement of indwelling IP port for chemotherapy infusion. Patients receive oxaliplatin and 5FU over 1-2 hours via IP infusion on days 1 and 15 of each cycle. Cycles repeat every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo diagnostic laparoscopy, biopsy, CT/MRI, and collection of blood samples at screening and on study and undergo collection of IP fluid samples on study. Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Diagnostic Laparoscopy; Drug: Fluorouracil; Procedure: Magnetic Resonance Imaging; Drug: Oxaliplatin; Procedure: Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
MTD will be determined based on isotonic regression. Specifically, the MTD will be selected as the dose for which the isotonic estimate of the toxicity rate is closest to the targeted dose limiting toxicities via Bayesian optimal interval software.
Measured: Up to 1 year
Incidence of adverse events
Adverse events (AEs) will be classified and attributed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 and will be summarized within and across dose levels using descriptive statistics. The overall number and percentage of patients experiencing AEs and toxicities will be summarized and reported as across all event types. All patients who have received at least one dose of the therapeutic agents will be evaluable for toxicity and tolerability.
Measured: Up to 30 days after completion of study treatment
Area under the curve
Will be computed using non-compartmental and compartmental methods. Will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, generalized estimating equations) to assess the pharmacokinetic markers in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Clearance
Will be computed using non-compartmental and compartmental methods. Will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, generalized estimating equations) to assess the pharmacokinetic markers in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Volume of distribution
Will be computed using non-compartmental and compartmental methods. Will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, generalized estimating equations) to assess the pharmacokinetic markers in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Half-life
Will be computed using non-compartmental and compartmental methods. Will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, generalized estimating equations) to assess the pharmacokinetic markers in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (5)
Tumor-cell intrinsic effects in response to IP 5FU+oxaliplatin
Samples obtained from baseline and after 4 cycles will be studied. Data collected will be descriptive and exploratory, and provide limited estimates of variability given the small sample sizes at each dose level. Results will be summarized using descriptive statistics (i.e., means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data.
Measured: Up to 16 weeks
Modulation of the tumor microenvironment in response to IP 5FU+oxaliplatin
Samples obtained from baseline and after 4 cycles will be studied. Data collected will be descriptive and exploratory, and provide limited estimates of variability given the small sample sizes at each dose level. Results will be summarized using descriptive statistics (i.e., means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data.
Measured: Up to 16 weeks
Changes in the makeup of circulating immune cells in response to IP 5FU+oxaliplatin
Samples obtained from baseline and after 4 cycles will be studied. Data collected will be descriptive and exploratory, and provide limited estimates of variability given the small sample sizes at each dose level. Results will be summarized using descriptive statistics (i.e., means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data.
Measured: Up to 16 weeks
Rate of conversion from unresectable to resectable
Resectable disease will be determined by peritoneal carcinomatosis index decreasing to < 20. Will be summarized and 95% exact binomial confidence interval will be provided.
Measured: At time of second laparoscopy, after 4 cycles of treatment (16 weeks)
Overall response rate
Will be evaluated using imaging criteria. Overall response rate (partial response + complete response) will be summarized and 95% exact binomial confidence interval will be provided.
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start31 Dec 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CarcinomaStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arjun Mittra
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Arjun Mittra, Ohio State University Comprehensive Cancer Center
- Investigators
- Arjun Mittra, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269978
- Sponsor's protocol ID
- OSU-23195
- Other IDs
- NCI-2023-10497, R21CA282536
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2024
- Last updated
- 9 Oct 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Intraperitoneal 5FU+Oxaliplatin in Patients With Colorectal Cancer With Isolated Peritoneal Metastasis
- ClinicalTrials.gov ID
- NCT06269978
- Acronym / sponsor ID
- OSU-23195
- Conditions
- Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Peritoneum, Stage IV Colorectal Cancer AJCC v8
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Arjun MittraUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 21 Feb 2024 (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.
This phase I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Fluorouracil stops cells from making DNA and it may kill cancer cells. Both oxaliplatin and fluorouracil are approved by the Food and Drug Administration to treat patients with colorectal cancer, however administration of these drugs directly into the area between the muscles and organs in the abdomen (intraperitoneal) for the treatment of peritoneal metastases is experimental. Giving oxaliplatin and fluorouracil directly into the peritoneal space may be a safe and effective way of treating patients with peritoneal metastases from colorectal cancer.
Detailed description
PRIMARY OBJECTIVES:
- Determine safety, tolerability, and maximally tolerated dose (MTD) of intraperitoneal (IP) fluorouracil (5FU)+oxaliplatin.
II. Determine pharmacokinetics (PK) of IP 5FU+oxaliplatin both in blood and peritoneal fluid.
SECONDARY OBJECTIVES:
- Determine tumor-cell intrinsic effects, modulation of the tumor immune microenvironment, and changes in the makeup of circulating immune cells in response to IP 5FU+oxaliplatin.
II. Identify preliminary response from IP 5FU+oxaliplatin: assess the rate of conversion from unresectable to resectable (determined by peritoneal carcinomatosis index [PCI] decreasing to < 20) and response rates by imaging criteria.
OUTLINE: This is a dose-escalation study of 5FU and oxaliplatin followed by a dose-expansion study.
Patients undergo placement of indwelling IP port for chemotherapy infusion. Patients receive oxaliplatin and 5FU over 1-2 hours via IP infusion on days 1 and 15 of each cycle. Cycles repeat every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo diagnostic laparoscopy, biopsy, computed tomography (CT)/magnetic resonance imaging (MRI), and collection of blood samples at screening and on study and undergo collection of IP fluid samples on study.
After completion of study treatment, patients are followed up for 30 days. Patients with confirmed disease progression or who start a new anti-cancer therapy are followed up every 12 weeks until death, withdrawal of consent, or end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (oxaliplatin, 5FU) | Experimental | Procedure: Biopsy, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Diagnostic Laparoscopy, Drug: Fluorouracil, Procedure: Magnetic Resonance Imaging, Drug: Oxaliplatin, Procedure: Surgical ProcedurePatients undergo placement of indwelling IP port for chemotherapy infusion. Patients receive oxaliplatin and 5FU over 1-2 hours via IP infusion on days 1 and 15 of each cycle. Cycles repeat every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo diagnostic laparoscopy, biopsy, CT/MRI, and collection of blood samples at screening and on study and undergo collection of IP fluid samples on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| BiopsyAlso: BIOPSY_TYPE, BxUndergo biopsy | Procedure or surgery | Treatment (oxaliplatin, 5FU) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood and IP fluid samples | Procedure or surgery | Treatment (oxaliplatin, 5FU) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (oxaliplatin, 5FU) |
| Diagnostic LaparoscopyUndergo diagnostic laparoscopy | Procedure or surgery | Treatment (oxaliplatin, 5FU) |
| FluorouracilAlso: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedioneGiven via IP infusion | Drug | Treatment (oxaliplatin, 5FU) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic ResonanceUndergo MRI | Procedure or surgery | Treatment (oxaliplatin, 5FU) |
| OxaliplatinAlso: 1-OHP, Ai Heng, Aiheng, DacotinGiven via IP infusion | Drug | Treatment (oxaliplatin, 5FU) |
| Surgical ProcedureAlso: Operation, Surgery, Surgery Type, Surgery, NOSUndergo placement of indwelling IP port | Procedure or surgery | Treatment (oxaliplatin, 5FU) |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Up to 1 year
MTD will be determined based on isotonic regression. Specifically, the MTD will be selected as the dose for which the isotonic estimate of the toxicity rate is closest to the targeted dose limiting toxicities via Bayesian optimal interval software.
Incidence of adverse events
Time frame: Up to 30 days after completion of study treatment
Adverse events (AEs) will be classified and attributed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 and will be summarized within and across dose levels using descriptive statistics. The overall number and percentage of patients experiencing AEs and toxicities will be summarized and reported as across all event types. All patients who have received at least one dose of the therapeutic agents will be evaluable for toxicity and tolerability.
Area under the curve
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Will be computed using non-compartmental and compartmental methods. Will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, generalized estimating equations) to assess the pharmacokinetic markers in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.
Clearance
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Will be computed using non-compartmental and compartmental methods. Will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, generalized estimating equations) to assess the pharmacokinetic markers in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.
Volume of distribution
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Will be computed using non-compartmental and compartmental methods. Will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, generalized estimating equations) to assess the pharmacokinetic markers in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.
Half-life
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Will be computed using non-compartmental and compartmental methods. Will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, generalized estimating equations) to assess the pharmacokinetic markers in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.
5 secondary outcomes
Tumor-cell intrinsic effects in response to IP 5FU+oxaliplatin
Time frame: Up to 16 weeks
Modulation of the tumor microenvironment in response to IP 5FU+oxaliplatin
Time frame: Up to 16 weeks
Changes in the makeup of circulating immune cells in response to IP 5FU+oxaliplatin
Time frame: Up to 16 weeks
Rate of conversion from unresectable to resectable
Time frame: At time of second laparoscopy, after 4 cycles of treatment (16 weeks)
Overall response rate
Time frame: Up to 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- The JameslineLink provided by the sponsor.
- 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.
Arjun Mittra, MD principal investigator
Ohio State University Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biopsy, Biospecimen Collection and Computed Tomography in people with Metastatic Colorectal Carcinoma and Metastatic Malignant Neoplasm in the Peritoneum, run by Arjun Mittra at 2 sites 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 10 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Maximum tolerated dose (MTD) (time frame: Up to 1 year). The study lists 6 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 9 Oct 2026.