Oxaliplatin in PIPAC for Nonresectable Peritoneal Metastases of Digestive Cancers

• Status: Unknown status
• Trial end date: 2021-06-07
• Target enrollment: 0
• Participant gender: All

Summary

Current curative treatment of digestive peritoneal carcinomatosis consists of complete cytoreduction surgery associated with intraperitoneal chemotherapy. This treatment has important limits: a high morbimortality and the impossibility of repeating the sessions. The majority of patients are therefore treated with systemic chemotherapy, which despite its progress, remains palliative.

Pressurized Intraperitoneal aerosol chemotherapy (PIPAC) has many advantages: under laparoscopy, low morbidity, good intratumoral penetration of cytotoxics, possibility of repeating the sessions and low financial cost.

Therefore, the investigator propose a phase 1 study, in colorectal and stomach cancer, with oxaliplatin doses escalation in Pressurized Intraperitoneal aerosol chemotherapy. It would allow a better tumor response, with potentially few risks and thus improve survival in patients with digestive peritoneal carcinoses, increasing access to cytoreductive surgery.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Cancerologie de l'Ouest
• Treatments: Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

1. Patient age ≥ 18 years

2. Histological or cytological diagnosis of peritoneal carcinoma of colorectal, gastric or gray primitive

3. Having previously received at least 3 months of systemic chemotherapy for metastatic disease (type of chemotherapy left to the discretion of each investigator). Patients who received chemotherapy with bevacizumab (Avastin®) more than 2 months ago may be included.

4. Irritable or extensive peritoneal carcinosis:

Extended peritoneal carcinoma of gastric adenocarcinoma (PCI score> 5) Extended peritoneal carcinoma of adenocarcinoma (PCI score> 13) Extended peritoneal carcinoma of colorectal adenocarcinoma (PCI score> 15)

5. ECOG performance index < or = 2 (see Annex 8)

6. Life expectancy> 3 months

7. Peripheral neuropathy grade ≤ 1

8. Hematological function: Hemoglobin ≥ 9 g / dL, leukocytes ≥ 4000 / mm3, PNN ≥ 1500 / mm3, platelets ≥ 100 000 / mm3

9. creatinine clearance> 50 mL / min (cockcroft and Gault formula)

10. Hepatic function: Total bilirubin ≤ 1.5 x ULN, ASAT and ALAT ≤ 3 x ULN, Alkaline phosphatases ≤ 3 x ULN

11. Patient without deficiency or with partial deficiency in Dihydropyrimidine dehydrogenase (i.e. DPD)

12. Effective contraception for women of childbearing age

13. Informing the patient and obtaining free, informed and written consent signed by the patient and his / her investigator.

14. Affiliated subject or beneficiary of the social security scheme.

Exclusion Criteria:

1. Patients who received bevacizumab (Avastin®) less than 2 months ago can not be included

2. Extra-peritoneal metastases, except for less than 3 pulmonary nodules (each size <5mm)

3. Known hypersensitivity to Oxaliplatin

4. Complete deficiency of Dihydropyrimidine dehydrogenase (i.e. DPD)

5. Grade 1> grade 1 peripheral neuropathy due to or not with Oxaliplatin previously used

6. Active active or other serious underlying disease that may prevent the patient from receiving treatment

7. Intracranial or intraocular hypertension (ongoing at the time of inclusion)

8. Severe or Severe Heart Failure (ongoing at the time of inclusion)

9. Complete intestinal obstruction (ongoing at the time of inclusion)

10. Other concurrent cancer or history of cancer other than in situ cancer of treated cervix or basal cell carcinoma or squamous cell carcinoma

11. Pregnant or nursing women

12. Persons deprived of their liberty or under guardianship or unable to give their consent

13. Inability to submit to medical follow-up of the trial for geographical, social or psychological reasons

14. Long-term corticosteroids (duration> 3 months), except for weaning for at least 3 months