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Peritoneal CarcinosisPhase 1/2IPOXANCT02866903

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

A Phase 1/2 study testing intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy in people with Peritoneal Carcinosis, run by Hospices Civils de Lyon at 6 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Peritoneal Carcinosis
What is being tested?
intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
6 sitesFrance
Study dates
18 May 2017to Mar 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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;
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • peripheral sensory neuropathy grade ≥2
  • Pregnant or lactating women
  • Unable to give consent
  • Patient under legal protection measures
  • Refusal to participate in the study

Trial locations and contacts

6 sites in 1 country.

Benoit You, MD contact

(0)4 78 86 43 18 ext. +33

benoit.you@chu-lyon.fr

6 sites in 1 country

France6 sites, 6 recruiting

  • CHU Estaing

    Clermont-Ferrand, 63003

    Denis Pr PEZET, (0)4 73 75 04 94 ext. +33, dpezet@chu-clermontferrand.fr

    Not yet recruiting

  • Service de Chirurgie Digestive et de l'Urgence, CHU Albert Michallon

    Grenoble, 38700

    Catherine ARVIEUX, (0)4 76 76 92 96 ext. +33, carvieux@chu-grenoble.fr

    Not yet recruiting

  • Département de Chirurgie Cancérologique, Centre Léon Bérard

    Lyon, 69373

    Patrice PEYRAT, (0)4 78 78 26 37 ext. +33, patrice.peyrat@lyon.unicancer.fr

    Not yet recruiting

  • Service d'Oncologie Médicale, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

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

    Recruiting

  • Service de Chirurgie Digestive et Cancérologique, CHU NORD

    Saint-Etienne, 42055

    Jack PORCHERON, (0)4 77 82 83 37 ext. +33, jack.porcheron@chu-st-etienne.fr

    Karine ABBOUD, (0)4 77 12 77 17 ext. +33, karine.abboud@chu-st-etienne.fr

    Not yet recruiting

  • Service Oncologie Médicale, INSTITUT DE CANCEROLOGIE DE LA LOIRE (ICL)

    Saint-Priest-en-Jarez, 42270

    Léa SABAN-ROCHE, (0)4 77 91 70 21 ext. +33, léa.saban-roche@icloire.fr

    Not yet recruiting

Other trials in France

About this study

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.

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.

Being tested
intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy
Keywords
Peritoneal carcinosis, intraperitoneal (IP) OXAliplatin, Phase I/II dose escalation trial, FOLFIRI Bevacizumab chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapyDrug

    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

  • intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapyDrug

    systemic FOLFIRI chemotherapy

  • intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapyDrug

    bevacizumab

Study groups in NCT02866903
Study groupRoleWhat they receive
Patients with peritoneal carcinosisExperimentalPatients with peritoneal carcinosis of colorectal origin and uncertain resectability with an indication for systemic chemotherapy compatible with the FOLFIRI + bevacizumab combination.
Receives: Drug: intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (NCI CTCAE v4.0)

    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

    Measured: up to 14 days

  2. Dose Limiting Toxicities, DLT

    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

    Measured: up to 14 days

Secondary outcomes (5)

  1. Overall response rate according to RECIST

    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

    Measured: up to 4 months

  2. Peritoneal Cancer Index (PCI)

    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

    Measured: up to 4 months

  3. Adverse events (NCI CTCAE v4.0)

    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

    Measured: up to 5 months

  4. The quality of life (EORTC QLQ-C30)

    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 .

    Measured: up to 4 months

  5. The quality of life (EORTC QLQ-C29)

    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.

    Measured: up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study start18 May 2017
  3. Primary completionMar 2019 (estimated)
  4. Study completionMar 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866903
Sponsor's protocol ID
69HCL16_0134
Acronym
IPOXA
Status last verified
Sep 2017
First submitted
4 Aug 2016
Last updated
21 Sep 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy in people with Peritoneal Carcinosis, run by Hospices Civils de Lyon at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Benoit You, MD ((0)4 78 86 43 18 ext. +33, benoit.you@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (NCI CTCAE v4.0) (time frame: up to 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02866903.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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