Colorectal CancerPhase 1IPOX-FOLFIRINCT04158349
Intraperitoneal Oxaliplatin in Combo w IV mFOLFIRI for Peritoneal Carcinomatosis From Colorectal & Appendiceal Cancer
A Phase 1 study testing Oxaliplatin and mFOLFIRI in people with Colorectal Cancer and Appendiceal Cancer, run by University of Utah at 1 site in United States.
Trial summary
This study is a prospective, multi-center, open-label phase I trial designed to determine the maximun tolerated dose of IP oxaliplatin when given in combination with mFOLFIRI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Appendiceal Cancer, Peritoneal Carcinoma
- What is being tested?
- Oxaliplatin and mFOLFIRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 14 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male or female subject aged ≥ 18 years.
- Histopathologically or cytologically confirmed unresectable colon, rectal or appendiceal adenocarcinoma with synchronous or metachronous (defined as occurring > 6 months after initial diagnosis) peritoneal dissemination of disease. (Stage IV peritoneal-based disease only)
- Patient has active, measurable disease as defined by RECIST 1.1 and assessed by either abdominal CT/MRI.
- Patients must be willing and able as assessed the treating investigator to undergo placement of an IP catheter and a Port-A Cath, if not already present.
- Patients must have known satisfactory cardiopulmonary function as assessed by the treating investigator.
- ECOG Performance Status ≤ 2.
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- Adequate organ function as defined as:
- Hematologic:
- Absolute neutrophil count (ANC) > 1200/mm3
- Platelet count > 100,000/mm3
- Hepatic:
- Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN
- Coagulation:
- International normalized ratio (INR) ≤ 1.5
- Patients who are therapeutically anticoagulated and whose antithrombotic treatment can be withheld for operation are eligible.
- Renal:
- BUN and serum creatinine within normal limits.
- eGFR ≥50 mL/min/1.73m2 or creatinine clearance ≥50 mL/min by Cockcroft-Gault
- Negative serum or urine pregnancy test at screening for women of childbearing potential.
- Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last study treatment administration if the risk of conception exists.
- Recovery to baseline or ≤ Grade 1 CTCAE v.5 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy.
- Willing to return for follow-up.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- Sensory neuropathy > grade 1 from prior therapy.
- Known low or absent Dipyrimidine Dehydrogenase (DPD) activity.
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Patients with metastases outside the peritoneal cavity.
- The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
- Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
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- Other clinically significant disorders that would preclude safe study participation.
- Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.
- -Note: Patients on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.
- Known chronic hepatitis B virus (HBV) or hepatitis C virus infection with a detectable viral load.
- -Note: Patients with an undetectable HBV viral load on appropriate suppressive therapy are eligible. Patients with an undetectable HCV viral load on appropriate treatment are eligible.
- Live vaccinations, except flu and COVID within 4 weeks of cycle one day one and while on trial.
- Known prior severe hypersensitivity to platinum compounds, any of the investigational medication or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
- Subjects taking prohibited medications as described in Section 6.4.2. A washout period of prohibited medications for a period of at least 5 half-lives or 4 weeks, whichever is shorter, should occur prior to the start of treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: Phase I Trial of Intraperitoneal Oxaliplatin in Combination With Intravenous mFOLFIRI for Peritoneal Carcinomatosis From Colorectal and Appendiceal Cancer
This study is a prospective, multi-center, open-label phase I trial designed to determine the maximun tolerated dose of IP oxaliplatin when given in combination with mFOLFIRI.
Read the detailed description
This study is a prospective, multi-center, open-label phase I trial designed to determine the MTD of IP oxaliplatin when given in combination with mFOLFIRI. This will be conducted according to a traditional 3+3 dose-escalation schedule and halted once MTD is established.
After consent and once deemed eligible for trial participation, patients will receive four cycles of study therapy. During therapy, patients will be monitored for dose-limiting toxicities and adverse events. After completion of all four cycles patients will be followed until resolution of any ongoing study treatment-related adverse events, initiation of alternative treatment, and survival.
Study drug treatment will be administered on day one of a 14-day cycle and the DLT evaluation period will be defined as the first three cycles of combination treatment (from cycle one day one to the last day of cycle three). The severity of AEs will be graded according to the NCI-CTCAE version 5.0 A standard 3+3 dose escalation design will be used to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) while ensuring the safety and tolerability of the treatment. The study will test three dose levels of oxaliplatin.
Dose Level 2 105 mg/m2 IP every 2 weeks Subjects will be accrued in cohorts of 3 to 6 subjects per dose level starting at Dose Level 0 (85 mg/m2). Escalation will continue until DLT stopping rules are met or the highest dose level is reached.
- Conditions
- Colorectal Cancer, Appendiceal Cancer, Peritoneal Carcinoma
- Being tested
- Oxaliplatin, mFOLFIRI
- Medical subject headings
- Colorectal Neoplasms, Appendiceal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Subjects will be accrued in cohorts of 3 to 6 subjects per dose level starting at Dose Level 0 (85 mg/m2). Escalation will continue as described in the protocol until DLT stopping rules are met or the highest dose level is reached.
mFOLFIRIDrug
mFOLFIRI is a standardized chemotherapy regimen utilizing 5-fluorouracil, leucovorin, and irinotecan administered on day one of a 14-day cycle. 5-Fluorouracil, leucovorin, and irinotecan should be prepared and administered per the package insert and local institutional guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 0 | Experimental | Dose Level 0: 85 mg/m2 Oxaliplatin IP every 2 weeks Receives: Drug: Oxaliplatin; Drug: mFOLFIRI |
| Dose Level 1 | Experimental | Dose Level 1: 95 mg/m2 Oxaliplatin IP every 2 weeks Receives: Drug: Oxaliplatin; Drug: mFOLFIRI |
| Dose Level 2 | Experimental | Dose Level 2: 105 mg/m2 Oxaliplation IP every 2 weeks Receives: Drug: Oxaliplatin; Drug: mFOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the maximum tolerated dose of intraperitoneal (IP) oxaliplatin with systemic IV 5-fluorouracil, leucovorin, and irinotecan (mFOLFIRI) every 2 weeks in patients with unresectable peritoneal carcinomatosis of colorectal or appendiceal origin
The incidence of DLTs during the defined DLT period
Measured: One Cycle is 14 days. The DLT evaluation period will be defined as the first three cycles of combination treatment (from cycle one day one to the last day of cycle three (42days)
Secondary outcomes (3)
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment and the IP catheter will be measured.
To assess the safety and feasibility of IP oxaliplatin when administered with systemic mFOLFIRI in patients with peritoneal carcinomatosis of colorectal or appendiceal origin.
Measured: up to 3 years
The efficacy of IP oxaliplatin plus systemic mFOLFIRI in patients with peritoneal carcinomatosis of colorectal or appendiceal origin will be measured.
- Objective response rate (ORR) after four cycles of study therapy. ORR will be assessed by the number of patients obtaining a complete response plus the number of patients obtaining a partial response divided by the number of total response evaluable subjects.
Measured: up to 3 years
The efficacy of IP oxaliplatin plus systemic mFOLFIRI in patients with peritoneal carcinomatosis of colorectal or appendiceal origin will be measured.
- Overall survival (OS) will be assessed as the time from trial initiation until death by any cause.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start22 Mar 2021
- Primary completion14 May 2021
- Study completion14 May 2021
Why it stopped: PI Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study is a prospective, multi-center, open-label phase I trial designed to determine the MTD of IP oxaliplatin when given in combination with mFOLFIRI. This will be conducted according to a traditional 3+3 dose-escalation schedule and halted once MTD is established.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Lambert, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158349
- Sponsor's protocol ID
- HCI126164
- Acronym
- IPOX-FOLFIRI
- Status last verified
- Sep 2021
- First submitted
- 4 Nov 2019
- Last updated
- 27 Sep 2021
- 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 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Intraperitoneal Oxaliplatin in Combination With Intravenous mFOLFIRI for Peritoneal Carcinomatosis From Colorectal and Appendiceal Cancer
- ClinicalTrials.gov ID
- NCT04158349
- Acronym / sponsor ID
- IPOX-FOLFIRI / HCI126164
- Conditions
- Colorectal Cancer, Appendiceal Cancer, Peritoneal Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 8 Nov 2019 (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 study is a prospective, multi-center, open-label phase I trial designed to determine the maximun tolerated dose of IP oxaliplatin when given in combination with mFOLFIRI.
Detailed description
This study is a prospective, multi-center, open-label phase I trial designed to determine the MTD of IP oxaliplatin when given in combination with mFOLFIRI. This will be conducted according to a traditional 3+3 dose-escalation schedule and halted once MTD is established.
After consent and once deemed eligible for trial participation, patients will receive four cycles of study therapy. During therapy, patients will be monitored for dose-limiting toxicities and adverse events. After completion of all four cycles patients will be followed until resolution of any ongoing study treatment-related adverse events, initiation of alternative treatment, and survival.
Study drug treatment will be administered on day one of a 14-day cycle and the DLT evaluation period will be defined as the first three cycles of combination treatment (from cycle one day one to the last day of cycle three). The severity of AEs will be graded according to the NCI-CTCAE version 5.0 A standard 3+3 dose escalation design will be used to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) while ensuring the safety and tolerability of the treatment. The study will test three dose levels of oxaliplatin.
Dose Level 2 105 mg/m2 IP every 2 weeks Subjects will be accrued in cohorts of 3 to 6 subjects per dose level starting at Dose Level 0 (85 mg/m2). Escalation will continue until DLT stopping rules are met or the highest dose level is reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a prospective, multi-center, open-label phase I trial designed to determine the MTD of IP oxaliplatin when given in combination with mFOLFIRI. This will be conducted according to a traditional 3+3 dose-escalation schedule and halted once MTD is established.
| Arm | Type | Receives |
|---|---|---|
| Dose Level 0 | Experimental | Drug: Oxaliplatin, Drug: mFOLFIRIDose Level 0: 85 mg/m2 Oxaliplatin IP every 2 weeks |
| Dose Level 1 | Experimental | Drug: Oxaliplatin, Drug: mFOLFIRIDose Level 1: 95 mg/m2 Oxaliplatin IP every 2 weeks |
| Dose Level 2 | Experimental | Drug: Oxaliplatin, Drug: mFOLFIRIDose Level 2: 105 mg/m2 Oxaliplation IP every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Male or female subject aged ≥ 18 years.
- Histopathologically or cytologically confirmed unresectable colon, rectal or appendiceal adenocarcinoma with synchronous or metachronous (defined as occurring > 6 months after initial diagnosis) peritoneal dissemination of disease. (Stage IV peritoneal-based disease only)
- Patient has active, measurable disease as defined by RECIST 1.1 and assessed by either abdominal CT/MRI.
- Patients must be willing and able as assessed the treating investigator to undergo placement of an IP catheter and a Port-A Cath, if not already present.
- Patients must have known satisfactory cardiopulmonary function as assessed by the treating investigator.
Key exclusion criteria (14 listed)
- Sensory neuropathy > grade 1 from prior therapy.
- Known low or absent Dipyrimidine Dehydrogenase (DPD) activity.
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Patients with metastases outside the peritoneal cavity.
- The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
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 |
|---|---|---|
| OxaliplatinSubjects will be accrued in cohorts of 3 to 6 subjects per dose level starting at Dose Level 0 (85 mg/m2). Escalation will continue as described in the protocol until DLT stopping rules are met or the highest dose level is reached. | Drug | Dose Level 0, Dose Level 1, Dose Level 2 |
| mFOLFIRImFOLFIRI is a standardized chemotherapy regimen utilizing 5-fluorouracil, leucovorin, and irinotecan administered on day one of a 14-day cycle. 5-Fluorouracil, leucovorin, and irinotecan should be prepared and administered per the package insert and local institutional guidelines. | Drug | Dose Level 0, Dose Level 1, Dose Level 2 |
Primary outcome
Assess the maximum tolerated dose of intraperitoneal (IP) oxaliplatin with systemic IV 5-fluorouracil, leucovorin, and irinotecan (mFOLFIRI) every 2 weeks in patients with unresectable peritoneal carcinomatosis of colorectal or appendiceal origin
Time frame: One Cycle is 14 days. The DLT evaluation period will be defined as the first three cycles of combination treatment (from cycle one day one to the last day of cycle three (42days)
The incidence of DLTs during the defined DLT period
3 secondary outcomes
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment and the IP catheter will be measured.
Time frame: up to 3 years
The efficacy of IP oxaliplatin plus systemic mFOLFIRI in patients with peritoneal carcinomatosis of colorectal or appendiceal origin will be measured.
Time frame: up to 3 years
The efficacy of IP oxaliplatin plus systemic mFOLFIRI in patients with peritoneal carcinomatosis of colorectal or appendiceal origin will be measured.
Time frame: Up to 3 years
Results and safety
The study was stopped early (reason given: PI Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- 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.
Laura Lambert, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxaliplatin and mFOLFIRI in people with Colorectal Cancer and Appendiceal Cancer, run by University of Utah at 1 site 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 14 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: stopped early, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: PI Decision). Results are not available in the source record.
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?
Assess the maximum tolerated dose of intraperitoneal (IP) oxaliplatin with systemic IV 5-fluorouracil, leucovorin, and irinotecan (mFOLFIRI) every 2 weeks in patients with unresectable peritoneal carcinomatosis of colorectal or appendiceal origin (time frame: One Cycle is 14 days. The DLT evaluation period will be defined as the first three cycles of combination treatment (from cycle one day one to the last day of cycle three (42days)). 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 27 Sep 2021.