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Oxaliplatin in PIPAC for Nonresectable Peritoneal Metastases of Digestive Cancers (PIPOX)

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ClinicalTrials.gov Identifier: NCT03294252
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
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 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.


Condition or disease Intervention/treatment Phase
Digestive Cancer Drug: 5-Fluorouracil Drug: L-Folinic acid Drug: Oxaliplatin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I / II Dose Escalation of Oxaliplatin Via a Laparoscopic Approach of Aerosol Pressurized Intraperitoneal Chemotherapy for Nonresectable Peritoneal Metastases of Digestive Cancers (Stomach, Hail and Colorectal)
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : September 12, 2019
Estimated Study Completion Date : June 7, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: 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 CIPPA procedure (injection and nebulisation in intraperitoneal).
Drug: 5-Fluorouracil
Presentation: Concentrated solution for concentrated infusion in vials containing 250 mg, 500 mg, 1 g and 5 g, in 5 ml, 10 ml, 20 ml and 100 ml respectively, providing a 50 mg / ml solution. Dosage: 400mg / m2. Administration: IV. Day of administration: between 1 h and 24 h before CIPPA.

Drug: L-Folinic acid
Presentation: lyophilisate for parenteral use, dosed at 25 mg, and in the form of a solution for injection by IM or IV dosed at 25 mg / 2.5 ml. Dosage: 20mg / m2. Administration: IV. Day of administration: between 1 h and 24 h before CIPPA.
Other Name: ELVORIN

Drug: Oxaliplatin
Concentrated solution for infusion dosed with 50 mg and 100 mg. Dosage: depending on the dose range assigned to inclusion (from 90mg / m2 to 300mg / m2). Administration: the solution is packaged in a syringe which is subsequently used for injection and not in a conventional bag. The product is administered in a high-pressure injector, during the PIPAC. Day of administration : J1 of PIPAC




Primary Outcome Measures :
  1. maximal Tolerated Dose [ Time Frame: 8 to 12 weeks ]
    maximal tolerated dose 3x3 patients inclusion(modified fibonacci dose escalation)


Secondary Outcome Measures :
  1. cumulative toxicity after the end of the CIPPA sessions received (maximum 5) at the same dose level [ Time Frame: 24 months ]
    with CTC-AE scale

  2. overall survival [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294252


Contacts
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Contact: DUMONT Frederic, MD +33 2 40 67 99 00 frederic.dumont@ico.unicancer.fr
Contact: DEBEAUPUIS Emilie +33 2 40 67 99 00 emilie.debeaupuis@ico.unicancer.fr

Locations
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France
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69495
Contact: Naoual BAKRIN, MD       naoual.bakrin@chu-lyon.fr   
ICO René Gauducheau Recruiting
Saint-Herblain, France, 44805
Contact: DUMONT Frédéric, MD    +33 2 40 67 99 00    frederic.dumont@ico.unicancer.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
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Principal Investigator: DUMONT Frederic, MD Institut de Cancérologie de l'Ouest

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT03294252     History of Changes
Other Study ID Numbers: ICO-N-2016-03
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Cancerologie de l'Ouest:
PIPAC
oxaliplatin
peritoneal metastases
Additional relevant MeSH terms:
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Digestive System Neoplasms
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Gastrointestinal Diseases
Leucovorin
Folic Acid
Oxaliplatin
Fluorouracil
Levoleucovorin
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Hematinics