- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03253133
Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC (NIPOX)
Phase I Study Assessing Safety of Intraperitoneal Chemotherapy in Neoadjuvant Treatment of Peritoneal Carcinomatosis of Colorectal Origin
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Montpellier, France, 34298
- Institut réginal du Cancer de Montpellier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oxaliplatin
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. |
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
Association of chemotherapy by LV5FU or Folfiri according pratician choice
Oxycodone
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose
Time Frame: through study completion, an average of 3 year
|
To determine: - Maximum tolerated dose (MTD), |
through study completion, an average of 3 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve (AUC)
Time Frame: through study completion, an average of 3 year
|
To evaluate Long term pharmacokinetic profile of associated targeted agents in tumoral tissue
|
through study completion, an average of 3 year
|
Collaborators and Investigators
Investigators
- Study Chair: Olivia Sgarbura, Institut Regional Du Cancer de Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Digestive System Neoplasms
- Abdominal Neoplasms
- Carcinoma
- Peritoneal Neoplasms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Antineoplastic Agents
- Analgesics, Opioid
- Narcotics
- Oxaliplatin
- Oxycodone
Other Study ID Numbers
- ICM-URC2015/34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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