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Safety of Intraperitoneal (IP) OXAliplatin (OXA) in Association With Systemic FOLFIRI Bevacizumab Chemotherapy in Patients With Peritoneal Carcinosis (IPOXA)

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ClinicalTrials.gov Identifier: NCT02866903
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Peritoneal carcinosis (PC) corresponds to a locoregional extension into the peritoneum of rare primary peritoneal cancers, or more frequently distant extension of digestive cancers (colorectal or gastric) or gynecological (ovarian, fallopian tube, or endometrial). PC can be considered as a distinct oncological entity as its genesis, natural history, and response to systematic treatments differ to those of other metastases. The development of PC, observed in 25-35% of colorectal cancers, is generally considered as a unfavorable event in the course of the disease. The prognosis is defined by the possibility of complete resection, possibly after neoadjuvant treatment. The benefit provided by the combination of cytoreductive surgery and heated intraperitoneal chemotherapy (HIPEC) with respect to systemic chemotherapy in patients with PC of colorectal origin has been demonstrated based on overall survival in several randomized trials, among which one evaluated oxaliplatin. The evaluation of the clinical benefit-risk related to the repeated administration of non-hyperthermic intraperitoneal chemotherapy, as has been validated in ovarian cancer, in patients with PC of colorectal origin is already being investigated by several international teams.

The FOLFOXIRI + bevacizumab every 2 weeks is a modern therapeutic option in patients with this disease. The intraperitoneal rather than intravenous (IV) administration of oxaliplatin, in this combination, could increase the response of peritoneal lesions known to be relatively insensitive to IV chemotherapy.


Condition or disease Intervention/treatment Phase
Peritoneal Carcinosis Drug: intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IPOXA, Phase I/II Dose Escalation Trial Aiming to Evaluate the Safety of Intraperitoneal (IP) OXAliplatin (OXA) in Association With Systemic FOLFIRI Bevacizumab Chemotherapy in Patients With Peritoneal Carcinosis of Colorectal Origin and Uncertain Resectability.
Actual Study Start Date : May 18, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with peritoneal carcinosis
Patients with peritoneal carcinosis of colorectal origin and uncertain resectability with an indication for systemic chemotherapy compatible with the FOLFIRI + bevacizumab combination.
Drug: intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy
Intraperitoneal (IP) OXAliplatin (OXA) in association with systemic FOLFIRI bevacizumab chemotherapy Intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI (Irinotecan IV + 5-FU IV) bevacizumab chemotherapy in escalation dose (every 14 days) starting with the level 1

Drug: intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy
systemic FOLFIRI chemotherapy

Drug: intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy
bevacizumab




Primary Outcome Measures :
  1. Adverse events (NCI CTCAE v4.0) [ Time Frame: up to 14 days ]
    The safety of intraperitoneal (IP) administration of oxaliplatin in combination with systemic chemotherapy FOLFIRI + bevacizumab will be evaluated during the first cycle of therapy according to NCI CTCAE version 4.0

  2. Dose Limiting Toxicities, DLT [ Time Frame: up to 14 days ]
    The safety of intraperitoneal (IP) administration of oxaliplatin in combination with systemic chemotherapy FOLFIRI + bevacizumab will be evaluated during the first cycle of therapy according to Dose Limiting Toxicities


Secondary Outcome Measures :
  1. Overall response rate according to RECIST [ Time Frame: up to 4 months ]
    Clinical efficacy of intraperitoneal (IP) administration of oxaliplatin in combination with systemic FOLFIRI + bevacizumab assessed by the overall response rate according to RECIST version 1.1 criteria assessed by imaging (TAP scanner and / or MRI if contraindication) performed after 4 cycles, and / or after 8 cycles

  2. Peritoneal Cancer Index (PCI) [ Time Frame: up to 4 months ]
    Clinical efficacy of intraperitoneal (IP) administration of oxaliplatin in combination with systemic FOLFIRI + bevacizumab assessed by Peritoneal Cancer Index (PCI) performed after 4 cycles, and / or after 8 cycles

  3. Adverse events (NCI CTCAE v4.0) [ Time Frame: up to 5 months ]
    The safety of intraperitoneal (IP) administration of oxaliplatin in combination with systemic chemotherapy FOLFIRI + bevacizumab will be evaluated throughout the duration of treatment (4 months) and until the end of patient follow up (1 month after treatment discontinuation) according to NCI CTCAE version 4.0

  4. The quality of life (EORTC QLQ-C30) [ Time Frame: up to 4 months ]
    The quality of life will be evaluated throughout the duration of treatment (4 months max) after the end of cycle 2, 4, 6 and 8 of chemotherapy according to EORTC QLQ-C30 .

  5. The quality of life (EORTC QLQ-C29) [ Time Frame: up to 4 months ]
    The quality of life will be evaluated throughout the duration of treatment (4 months max) after the end of cycle 2, 4, 6 and 8 of chemotherapy according to EORTC QLQ-C29.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years old and ≤ 75 years old
  • ECOG Performance Status (PS) 0-2
  • Peritoneal carcinosis with locoregional extension or metastases of colorectal origin and uncertain resectability
  • PCI > 20 and / or infiltration of the hepatic pedicle and / or necessary digestive tract resections
  • Systemic chemotherapy indication, compatible with the FOLFIRI + bevacizumab combination
  • Satisfactory haematological evaluation: PNN rate greater than 1500 / mm3, platelet count greater than 100 G / l;
  • Satisfactory renal and hepatic function : serum creatinine ≤1.5 times the normal lower values or creatinine clearance ≥50 ml / min, bilirubin ≤1.25 times lower normal values, AST / ALT ≤1.5 times the lower normal values (≤5 times the lower normal values for patients with liver metastases)
  • No unstable conditions: myocardial infarction within 6 months prior to the start of the study, congestive heart failure, unstable angina, active cardiomyopathy, unstable rhythm disorder, uncontrolled hypertension, uncontrolled psychiatric disorders, severe infection, peptic ulcer or any condition that could be aggravated by treatment or limit compliance (investigator assessment);
  • No limitation in the number of previous treatments;
  • Patients may have received conventional cytotoxic chemotherapy , hormonal or immunological targeted biological agents. They should have recovered from previous grade ≤2 toxicities
  • Written informed consent
  • Known RAS status.

Exclusion Criteria:

  • Extraperitoneal metastases for which the site or number preclude potentially curative surgery at any moment during the course of the disease
  • Sign of bowel obstruction or lesions whose topography indicates a risk of intestinal perforation or inflammatory bowel disease
  • ECOG PS 3-4
  • Contraindication to the placement of a intraperitoneal central line
  • Contraindication specifically related to intraperitoneal administration of oxaliplatin
  • known history of hypersensitivity to oxaliplatin or to the excipients
  • peripheral sensory neuropathy grade ≥2
  • Pregnant or lactating women
  • Unable to give consent
  • Patient under legal protection measures
  • Refusal to participate in the study

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): NCT02866903


Contacts
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Contact: Benoit You, MD (0)4 78 86 43 18 ext +33 benoit.you@chu-lyon.fr

Locations
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France
CHU Estaing Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Denis Pr PEZET    (0)4 73 75 04 94 ext +33    dpezet@chu-clermontferrand.fr   
Service de Chirurgie Digestive et de l'Urgence, CHU Albert Michallon Not yet recruiting
Grenoble, France, 38700
Contact: Catherine ARVIEUX    (0)4 76 76 92 96 ext +33    carvieux@chu-grenoble.fr   
Département de Chirurgie Cancérologique, Centre Léon Bérard Not yet recruiting
Lyon, France, 69373
Contact: Patrice PEYRAT    (0)4 78 78 26 37 ext +33    patrice.peyrat@lyon.unicancer.fr   
Service d'Oncologie Médicale, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69495
Contact: Benoit You, MD    (0)4 78 86 43 18 ext +33    benoit.you@chu-lyon.fr   
Service Oncologie Médicale, INSTITUT DE CANCEROLOGIE DE LA LOIRE (ICL) Not yet recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Léa SABAN-ROCHE    (0)4 77 91 70 21 ext +33    léa.saban-roche@icloire.fr   
Service de Chirurgie Digestive et Cancérologique, CHU NORD Not yet recruiting
Saint-Étienne, France, 42055
Contact: Jack PORCHERON    (0)4 77 82 83 37 ext +33    jack.porcheron@chu-st-etienne.fr   
Contact: Karine ABBOUD    (0)4 77 12 77 17 ext +33    karine.abboud@chu-st-etienne.fr   
Principal Investigator: Karine ABBOUD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Benoit You, MD Service d'Oncologie Médicale, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud 69495 Pierre-Bénite

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02866903     History of Changes
Other Study ID Numbers: 69HCL16_0134
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017

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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 Hospices Civils de Lyon:
Peritoneal carcinosis
intraperitoneal (IP) OXAliplatin
Phase I/II dose escalation trial
FOLFIRI Bevacizumab chemotherapy

Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bevacizumab
Oxaliplatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors