Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC

NCT ID: NCT03253133

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-10
• Study Completion Date: 2023-04-24

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

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

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

Intervention Type: DRUG

Association of chemotherapy by LV5FU or Folfiri according pratician choice

Oxycodone

Intervention Type: DRUG

Oxycodone

Interventions

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

Intervention Type: DRUG

LV5FU or Folfiri

Association of chemotherapy by LV5FU or Folfiri according pratician choice

Intervention Type: DRUG

Oxycodone

Oxycodone

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivia Sgarbura

Role: STUDY_CHAIR

Institut régional du Cancer de Montpellier

Locations

Institut réginal du Cancer de Montpellier

Montpellier, , France

Countries

France

Other Identifiers

ICM-URC2015/34

Identifier Type: -

Identifier Source: org_study_id