Colorectal CancerPhase 1NIPOXNCT03253133
Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC
A Phase 1 study testing Oxaliplatin, LV5FU or Folfiri and Oxycodone in people with Colorectal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
This study determine the maximal tolerate dose Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Oxaliplatin, LV5FU or Folfiri and Oxycodone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2016to 24 Apr 2023
- 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
- Patients aged over 18 years old
- Histologically confirmed diagnosis of colorectal or appendix cancer
- Peritoneal carcinomatosis of colorectal origin, presumed unresecable or non-optimally resecable, assessed by imaging (CT scan (Computed Tomography Scanner) and MRI (Magnetic Resonance Imaging)) or during a previous abdominal surgery
- Peritoneal Carcinomatosis Index > 17
- Previous adjuvant chemotherapy is allowed
- One or several lines of chemotherapy are allowed
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- Hemoglobin ≥ 10 g/dL (red blood transfusion is allowed if needed), neutrophils ≥ 1.500/mm3, platelets ≥ 100.000/mm3 and white blood cells > 3000 /mm3
- Total bilirubin ≤ 1.5 Upper limit of normal (ULN), ALT or AST ≤ 3 ULN
- Serum creatinine ≤ 1.5 ULN ; Serum calcium ≥ LLN and ≤ 1.2 x UNL ; Serum magnesium ≥ LLN and ≤ 1.2 x UNL ; Kalemia ≥ LLN
- ECOG (Eastern Cooperative Oncology group) < 1
- Life expectancy higher than 8 weeks
- Negative pregnancy test in women of childbearing potential
- Use of an effective contraceptive method during the whole treatment and up to 6 months after the completion of treatment
- Patients affiliated to a French Social Security System
- Signed informed consent (IC) obtained before any study specific procedures
Who cannot join
- Serum uracile ≥ 16 ng/ml
- Extra peritoneal metastatic disease (except ovarian metastases and retroperitoneal nodes)
- Patients with anesthetic or medical contraindications to surgery
- Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF
- Patients previously treated with cytoreduction and followed by an intra-peritoneal chemotherapy within the past 6 months.
- Anticancer therapy (e.g. chemotherapy, radiotherapy, targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion
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- History or presence of other cancer within the past 5 years (except adequately treated in situ carcinoma of the cervix and non-melanoma skin cancer)
- Pregnant or breastfeeding women
- Known positive test for human immunodeficiency virus (HIV), hepatitis B or C virus or patients with untreated serious infections
- Participation in another clinical trial within 30 days prior to study entry
- Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study
- ECG with a QT/QTc interval higher than 450 ms for men and higher than 470 ms for women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study Assessing Safety of Intraperitoneal Chemotherapy in Neoadjuvant Treatment of Peritoneal Carcinomatosis of Colorectal Origin
This study determine the maximal tolerate dose
Read the detailed description
This study determine the maximal tolerate dose for the patient treated by intraperitoneal chemotherapy in neoadjuvant treatment of peritoneal carcinomatosis of colorectal origin
- Conditions
- Colorectal Cancer
- Being tested
- Oxaliplatin, LV5FU or Folfiri, Oxycodone
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Dose levels of Oxaliplatin:
4 dose levels of Oxaliplatin (85, 100, 130 and 160 mg/m²) are planned. 1 dose level is planned (-1 : 70 mg/m²) if DLT is reached at level 1
Table 1: Dose levels
Dose Level Dose (mg/m²) Number of patients DL -1 70 mg 3-6 DL 1 * 85 mg 3-6 DL 2 100 mg 3-6 DL 3 130 mg 3-6 DL 4 160 mg 3-6
- Start level
LV5FU or FolfiriDrug
Association of chemotherapy by LV5FU or Folfiri according pratician choice
OxycodoneDrug
Oxycodone
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin | Experimental | IP neoadjuvant chemotherapy protocol:
Oxaliplatine will be administered in IP in a total solution of 2L of serum G5%. A continuous infusion pump of Oxycodone would be administered for the entire duration of the intraperitoneal chemotherapy. Perfusion time for the intraperitoneal chemotherapy is estimated but not limited to one and a half hour.
Intravenous chemotherapy protocol:
Associated Intravenous (systemic) chemotherapy is administered during IP chemotherapy including at least LVFU2 (5FU-Leucovorin) or FOLFIRI (5FU-Irinotecan) regimens and targeted therapy if needed. Receives: Drug: Oxaliplatin; Drug: LV5FU or Folfiri; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
To determine:
- Maximum tolerated dose (MTD),
Measured: through study completion, an average of 3 year
Secondary outcomes (1)
Area Under the Curve (AUC)
To evaluate Long term pharmacokinetic profile of associated targeted agents in tumoral tissue
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start10 May 2016
- Primary completion28 Oct 2020
- Study completion24 Apr 2023
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 Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivia Sgarbura, Study chair, Institut régional du Cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253133
- Sponsor's protocol ID
- ICM-URC2015/34
- Acronym
- NIPOX
- Status last verified
- May 2023
- First submitted
- 29 Aug 2016
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Assessing Safety of Intraperitoneal Chemotherapy in Neoadjuvant Treatment of Peritoneal Carcinomatosis of Colorectal Origin
- ClinicalTrials.gov ID
- NCT03253133
- Acronym / sponsor ID
- NIPOX / ICM-URC2015/34
- Conditions
- Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 17 Aug 2017 (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 determine the maximal tolerate dose
Detailed description
This study determine the maximal tolerate dose for the patient treated by intraperitoneal chemotherapy in neoadjuvant treatment of peritoneal carcinomatosis of colorectal origin
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin | Experimental | Drug: Oxaliplatin, Drug: LV5FU or Folfiri, Drug: OxycodoneIP neoadjuvant chemotherapy protocol: Oxaliplatine will be administered in IP in a total solution of 2L of serum G5%. A continuous infusion pump of Oxycodone would be administered for the entire duration of the intraperitoneal chemotherapy. Perfusion time for the intraperitoneal chemotherapy is estimated but not limited to one and a half hour. Intravenous chemotherapy protocol: Associated Intravenous (systemic) chemotherapy is administered during IP chemotherapy including at least LVFU2 (5FU-Leucovorin) or FOLFIRI (5FU-Irinotecan) regimens and targeted therapy if needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients aged over 18 years old
- Histologically confirmed diagnosis of colorectal or appendix cancer
- Peritoneal carcinomatosis of colorectal origin, presumed unresecable or non-optimally resecable, assessed by imaging (CT scan (Computed Tomography Scanner) and MRI (Magnetic Resonance Imaging)) or during a previous abdominal surgery
- Peritoneal Carcinomatosis Index > 17
- Previous adjuvant chemotherapy is allowed
Key exclusion criteria (12 listed)
- Serum uracile ≥ 16 ng/ml
- Extra peritoneal metastatic disease (except ovarian metastases and retroperitoneal nodes)
- Patients with anesthetic or medical contraindications to surgery
- Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF
- Patients previously treated with cytoreduction and followed by an intra-peritoneal chemotherapy within the past 6 months.
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 |
|---|---|---|
| OxaliplatinDose levels of Oxaliplatin: 4 dose levels of Oxaliplatin (85, 100, 130 and 160 mg/m²) are planned. 1 dose level is planned (-1 : 70 mg/m²) if DLT is reached at level 1 Table 1: Dose levels Dose Level Dose (mg/m²) Number of patients DL -1 70 mg 3-6 DL 1 * 85 mg 3-6 DL 2 100 mg 3-6 DL 3 130 mg 3-6 DL 4 160 mg 3-6 * Start level | Drug | Oxaliplatin |
| LV5FU or FolfiriAssociation of chemotherapy by LV5FU or Folfiri according pratician choice | Drug | Oxaliplatin |
| OxycodoneOxycodone | Drug | Oxaliplatin |
Primary outcome
Maximum tolerated dose
Time frame: through study completion, an average of 3 year
To determine: - Maximum tolerated dose (MTD),
1 secondary outcome
Area Under the Curve (AUC)
Time frame: through study completion, an average of 3 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- 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.
Olivia Sgarbura study chair
Institut régional du Cancer de Montpellier
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, LV5FU or Folfiri and Oxycodone in people with Colorectal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
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 15 inclusion and 12 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: finished, as of the sponsor's last update on 3 May 2023. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: through study completion, an average of 3 year). 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 3 May 2023.