Combination of PIPAC and systemic chemotherapy for advanced ovarian cancer

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

This study is testing a new way to give chemotherapy for women with advanced ovarian cancer who haven't responded well to previous treatments, by combining a special spray method with regular chemotherapy to see how safe it is and what the best dose is.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Hospices Civils de Lyon (Academic / other)
• Drugs / interventions: chemotherapy, doxorubicin
• Locations: 6 sites (Lille and 5 other locations)
• Trial ID: NCT04811703 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and maximum tolerated dose of pressurized intraperitoneal aerosol chemotherapy (PIPAC) combined with systemic chemotherapy in women with advanced ovarian cancer who have not responded sufficiently to prior treatments. Participants will receive three cycles of PIPAC chemotherapy alternating with intravenous chemotherapy over a period of 12 weeks. The study employs a Continual Reassessment Method (CRM) to guide dose escalation based on observed toxicities. The primary goal is to establish the recommended dose for future phase II trials.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 75 with advanced epithelial ovarian, fallopian tube, or peritoneal carcinoma who have not responded adequately to prior chemotherapy.

Not a fit: Patients with stable pathologies or those who have had a myocardial infarction within the last six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for women with advanced ovarian cancer who have limited options due to insufficient tumor response.

How similar studies have performed: While the combination of PIPAC and systemic chemotherapy is a novel approach, similar studies have shown promise in improving treatment for peritoneal carcinomatosis.

Eligibility 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)

Where this trial is running

Lille and 5 other locations

• Hôpital Claude Huriez - Chirurgie générale et digestive — Lille, France (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)
• Hôpital Lyon Sud - Chirurgie Gynécologique et oncologique-obstétrique — Pierre-Bénite, France (Recruiting)
• Hôpital Lyon Sud - Oncologie Médicale — Pierre-Bénite, France (Recruiting)

Study contacts

• Principal investigator: Justine ARQUILLIERE, MD — Hospices Civils de Lyon
• Study coordinator: Justine ARQUILLIERE, MD

Conditions Metastatic Ovarian Carcinoma; Peritoneal Carcinomatosis; Stage III Ovarian Cancer; Stage IV Ovarian Cancer; Stage III Fallopian Tube Cancer; Stage IV Fallopian Tube Cancer; Metastatic Malignant Neoplasm in the Peritoneum; Dose escalation