Oxaliplatin in PIPAC for Nonresectable Peritoneal Metastases of Digestive Cancers

Phase 1

Terminated

• Conditions: Digestive Cancer
• Interventions: Drug: 5-Fluorouracil; Drug: L-Folinic acid; Drug: Oxaliplatin

• Registration Number: NCT03294252
• Lead Sponsor: Institut Cancerologie de l'Ouest

Brief 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 prog...

Detailed Description

The objective of this study is to determine the maximum tolerated dose (mtd) of oxaliplatin to be used during PIPAC.

Study design is a phase I/II, multicentre, non-comparative, non-randomised dose escalation clinical trial.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-24
• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-27
• Primary Completion: 2019-02-05
• Study Completion: 2021-10-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Patient age ≥ 18 years 2. Histological or cytological diagnosis or suspicion of peritoneal carcinosis of colorectal, gastric or bowel origin 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 bevacizumab (Avastin®) can be included if and only if the time between the last treatment administered and the first PIPAC received is at least 4 weeks 4. ECOG performance index < or = 2 5. Life expectancy> 3 months 6. Peripheral neuropathy grade ≤ 1 7. Hematological function: Hemoglobin ≥ 9 g / dL, leukocytes ≥ 4000 / mm3, PNN ≥ 1500 / mm3, platelets ≥ 100 000 / mm3 8. Creatinine clearance> 50 mL / min (cockcroft and Gault formula) 9. Hepatic function: Total bilirubin ≤ 1.5 x ULN, ASAT and ALAT ≤ 3 x ULN, Alkaline phosphatases ≤ 3 x ULN 10 . Patients with no known or partial deficiency of Dihydropyrimidine dehydrogenase (i.e. DPD) 11. 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.

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

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Exclusion Criteria

1. Patients who received bevacizumab (Avastin®) less than 4 weeks 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. Known complete dihydropyrimidine dehydrogenase (i.e. DPD) deficiency
5. Peripheral neuropathy Grade >1 due to or not with Oxaliplatin previously used
6. 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxaliplatin	5-Fluorouracil	The experimental drugs used in this protocol are Oxaliplatin, 5-Fluorouracil and L-Folinic acid. All are used as part of their marketing authorization, with the exception of Oxaliplatin as regards its mode of administration specific to the PIPAC procedure (injection and nebulisation in intraperitoneal).
Oxaliplatin	L-Folinic acid	The experimental drugs used in this protocol are Oxaliplatin, 5-Fluorouracil and L-Folinic acid. All are used as part of their marketing authorization, with the exception of Oxaliplatin as regards its mode of administration specific to the PIPAC procedure (injection and nebulisation in intraperitoneal).
Oxaliplatin	Oxaliplatin	The experimental drugs used in this protocol are Oxaliplatin, 5-Fluorouracil and L-Folinic acid. All are used as part of their marketing authorization, with the exception of Oxaliplatin as regards its mode of administration specific to the PIPAC procedure (injection and nebulisation in intraperitoneal).

Primary Outcome Measures

Name	Time	Method
Maximal Tolerated Dose	8 to 12 weeks	Maximal tolerated dose 3x3 patients inclusion(modified fibonacci dose escalation)
Recommanded dose for the extension phase	8 to 12 weeks	Dose level below the maximum tolerated dose

Secondary Outcome Measures

Name	Time	Method
Cumulative toxicity after the end of the PIPAC sessions received (maximum 5) at the same dose level	24 months after the last PIPAC received	with CTC-AE scale
Overall survival	24 months after the last PIPAC received	Median overall survival at the end of the study
Progression-Free Survival	12 months after the last PIPAC received	Median PFS, time between the first PIPAC received and progression or death in absence of progression

Trial Locations

Locations (3)

ICO René Gauducheau; 🇫🇷 Saint-Herblain, France

Hopital Begin; 🇫🇷 Saint-Mandé, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France