Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC

Colorectal Cancer Clinical Trial

— NIPOX  

Official title:

Phase I Study Assessing Safety of Intraperitoneal Chemotherapy in Neoadjuvant Treatment of Peritoneal Carcinomatosis of Colorectal Origin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253133
• Other study ID #: ICM-URC2015/34
• Status: Completed
• Phase: Phase 1
• Start date: May 10, 2016
• Est. completion date: April 24, 2023

Study information

• Verified date: May 2023
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study determine the maximal tolerate dose

Description:

This study determine the maximal tolerate dose for the patient treated by intraperitoneal chemotherapy in neoadjuvant treatment of peritoneal carcinomatosis of colorectal origin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 24, 2023
• Est. primary completion date: October 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• Oxaliplatin
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 Folfiri
Association of chemotherapy by LV5FU or Folfiri according pratician choice
• Oxycodone
Oxycodone

Locations

Country	Name	City	State
France	Institut réginal du Cancer de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose	To determine: - Maximum tolerated dose (MTD),	through study completion, an average of 3 year
Secondary	Area Under the Curve (AUC)	To evaluate Long term pharmacokinetic profile of associated targeted agents in tumoral tissue	through study completion, an average of 3 year