Recruiting

PIPACOVAPhase I Dose Escalation Study Evaluating the Safety of Adding Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin-doxorubicin to the Systemic Chemotherapy, and the Recommended Phase II Dose, in Women With Insufficient Response to Carboplatin-paclitaxel for Advanced Epithelial Cancer of the Ovary, Fallopian Tubes or Peritoneum

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What is being tested

Combined PIPAC / IV chemotherapy treatment

Drug
Who is being recruted

Abdominal Neoplasms+23

+ Carcinoma, Ovarian Epithelial

+ Urogenital Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2021
See protocol details

Summary

Principal SponsorHospices Civils de Lyon
Study ContactNaoual BAKRIN, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 30, 2021

Actual date on which the first participant was enrolled.

Women with history of tumor response insufficient to allow complete cytoreductive surgery after three cycles of previous neoadjuvant systemic carboplatin-paclitaxel chemotherapy will be prospectively recruited in this trial. After signed consent and if unresectability is confirmed, patients will undergo three cycles of doxorubicin-cisplatin PIPAC chemotherapy associated with systemic carboplatin-paclitaxel chemotherapy (alternating PIPAC and intravenous chemotherapy sessions over 3 cycles of 4 weeks). The primary objective of the study is to determine the maximum tolerated dose (MDT). During cycle 1, limiting dose toxicity must be collected as soon as it is known. Each patients will be treated at the dose recommended by the CRM (Continual Reassessment Method ) algorithm conditional on dose-limiting toxicity during Cycle 1. The dose escalation will be guided by CRM to determine the recommended dose of PIPAC chemotherapy for phase II trial. Secondary objectives are : * to evaluate the anatomopathological response, the radiologic tumoral response and the evolution of the peritoneal cancer extent, to the combined chemotherapy * to describe the pharmacokinetic of the PIPAC chemotherapy * to investigate the KELIM parameter as a predictive marker in the response sensitivity of the combined chemotherapy treatment * and to evaluate the safety of the combined chemotherapy. During the first day of the first cycle, blood samples will be collected to measure doxorubicin and cisplatin (pharmacokinetic study). Along these 3 cycles, the dose of antigen CA-125 will be performed before each chemotherapies (intraperitoneal or intravenous). At the end of combined chemotherapy treatment, patients will undergo radiologic tumoral response by imaging assessment (scanner or MRI) and a last dosage of CA-125 will be realized.. In case of a complete / partial response / stabilization (RECIST criteria v.1.) on the imaging, re-evaluation for resectability will be done. If resectable disease, cytoreductive surgery will be programmed and a post-operative visit 1 month later will be realized. Otherwise for patients with progress disease or unresectable the participation in the study will be finished.

Official TitlePhase I Dose Escalation Study Evaluating the Safety of Adding Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin-doxorubicin to the Systemic Chemotherapy, and the Recommended Phase II Dose, in Women With Insufficient Response to Carboplatin-paclitaxel for Advanced Epithelial Cancer of the Ovary, Fallopian Tubes or Peritoneum
NCT04811703
Principal SponsorHospices Civils de Lyon
Study ContactNaoual BAKRIN, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Abdominal NeoplasmsCarcinoma, Ovarian EpithelialUrogenital DiseasesGenital DiseasesAdnexal DiseasesCarcinomaDigestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsFallopian Tube DiseasesFallopian Tube NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOvarian DiseasesOvarian NeoplasmsPeritoneal DiseasesPeritoneal NeoplasmsUrogenital NeoplasmsFemale Urogenital Diseases

Criteria

Inclusion Criteria: * Age ≥18 years and ≤ 75 years * ECOG PS 0-2 ; * Epithelial stage IIb to IVa carcinoma of the ovary, fallopian tubes, or peritoneum proven histologically, stage III or IV of the FIGO classification and with history of insufficient tumor response/ after three cycles of previous neoadjuvant systemic carboplatin-paclitaxel chemotherapy as judged by the investigators after discussion and validation in Multidisciplinary Team ; * Adequate hematologic function * Absolute Neutrophil Count \> 1500 / mm3 (or 1.5 10 9/L) * Hemoglobin ≥ 9.0 g/dL, * platelets \> 100 G/L, * Adequate hepatic and renal function: * Serum creatinine ≤1.5 times upper normal values or glomerular filtration rate ≥ 60 mL/min/1.73 m2 estimated by the CKD-EPI equation * Total bilirubin ≤1.5 times the upper normal limit, * ASAT / ALAT ≤1.5 times the upper normal limit (≤5 times upper normal limits for patients with liver metastases); * Absence of unstable pathologies : 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 pathology that could be aggravated by treatment or limit compliance (investigator's judgment) * Patient information given and Written informed consent obtained prior to the initiation of any specific study procedure * Affiliated to a social insurance regime or similar Exclusion Criteria: * Extra-peritoneal metastases (position or number which make the disease unresectable) * Signs of intestinal obstruction or lesions with risk of intestinal perforation, or signs of inflammatory disease of the digestive tract * Contraindication to systemic chemotherapy CARBOPLATIN-PACLITAXEL :known allergy to paclitaxel * Contraindication to the PIPAC procedure: * Known allergy to cisplatin or other platinum-containing compounds * Known allergy to doxorubicin or other anthracyclines or anthracenediones; * Heart failure with myocardial insufficiency * Uncontrolled coronary insufficiency; * Pregnancy or breastfeeding * Persons deprived of liberty or under guardianship ; * Major patient protected by the Law; * Persons participating in other research with an exclusion period still in progress at the time of inclusion or research that may interfere with the results of the present study (investigator's judgment) ; * Impossibility to submit to the medical follow-up of the trial for geographical, social or psychic reasons (investigator's judgement)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients will undergo 3 cycles of combined chemotherapy, consisting of PIPAC (cisplatin-doxorubicin, escalating doses) and systemic chemotherapy (paclitaxel-carboplatine, standard doses). First patient will be treated at the lowest dose: doxorubicin 2.1 mg/m² and cisplatin 10.5 mg/m². Subsequent patients will be treated at the dose recommended by the CRM algorithm in the absence of dose-limiting toxicity. A total of 11 dose levels with a factor between 1 and 3 are considered. The maximum dose considered will be doxorubicin, 6.3 mg/m² and cisplatin, 31.5 mg/m². The doses of intravenous chemotherapy will be defined in a standard way, according to the habits of the investigating clinicians and in accordance with the doses received previously. Each cycle will last 28 days and will begin at day 1 with PIPAC procedure and will be completed at day 8 with systemic chemotherapy. Combined chemotherapy will be repeated every 4 weeks for up to 3 cycles in the absence of unacceptable toxicity.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Recruiting

Hôpital Claude Huriez - Chirurgie générale et digestive

Lille, FranceOpen Hôpital Claude Huriez - Chirurgie générale et digestive in Google Maps
Recruiting

Hôpital Claude Huriez - Oncologie médicale

Lille, France
Recruiting

Hôpital de la Croix-Rousse

Lyon, France
Recruiting

Hôpital Lyon Sud - Chirurgie Digestive et Oncologique

Pierre-Bénite, France
Recruiting
6 Study Centers
PIPACOVA | Phase I Dose Escalation Study Evaluating the Safety of Adding Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin-doxorubicin to the Systemic Chemotherapy, and the Recommended Phase II Dose, in Women With Insufficient Response to Carboplatin-paclitaxel for Advanced Epithelial Cancer of the Ovary, Fallopian Tubes or Peritoneum | PatLynk