Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC

• Status: Completed
• Trial end date: 2020-10-28
• Target enrollment: 0
• Participant gender: All

Summary

This study determine the maximal tolerate dose

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Treatments: Oxaliplatin; Oxycodone

Criteria

Inclusion Criteria:

1. Patients aged over 18 years old

2. Histologically confirmed diagnosis of colorectal or appendix cancer

3. 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

4. Peritoneal Carcinomatosis Index > 17

5. Previous adjuvant chemotherapy is allowed

6. One or several lines of chemotherapy are allowed

7. 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

8. Total bilirubin ≤ 1.5 Upper limit of normal (ULN), ALT or AST ≤ 3 ULN

9. Serum creatinine ≤ 1.5 ULN ; Serum calcium ≥ LLN and ≤ 1.2 x UNL ; Serum magnesium ≥ LLN and ≤ 1.2 x UNL ; Kalemia ≥ LLN

10. ECOG (Eastern Cooperative Oncology group) < 1

11. Life expectancy higher than 8 weeks

12. Negative pregnancy test in women of childbearing potential

13. Use of an effective contraceptive method during the whole treatment and up to 6 months after the completion of treatment

14. Patients affiliated to a French Social Security System

15. Signed informed consent (IC) obtained before any study specific procedures

Exclusion Criteria:

1. Serum uracile ≥ 16 ng/ml

2. Extra peritoneal metastatic disease (except ovarian metastases and retroperitoneal nodes)

3. Patients with anesthetic or medical contraindications to surgery

4. Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF

5. Patients previously treated with cytoreduction and followed by an intra-peritoneal chemotherapy within the past 6 months.

6. Anticancer therapy (e.g. chemotherapy, radiotherapy, targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion

7. 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)

8. Pregnant or breastfeeding women

9. Known positive test for human immunodeficiency virus (HIV), hepatitis B or C virus or patients with untreated serious infections

10. Participation in another clinical trial within 30 days prior to study entry

11. Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study

12. ECG with a QT/QTc interval higher than 450 ms for men and higher than 470 ms for women