Status:
COMPLETED
Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03253133
Start Date
May 10 2016
End Date
April 24 2023
Last Update
May 3 2023
Active Locations (1)
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1
Institut réginal du Cancer de Montpellier
Montpellier, France, 34298