Actively Recruiting
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer
Led by Hospices Civils de Lyon · Updated on 2024-09-19
15
Participants Needed
6
Research Sites
283 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 75 years
- ECOG performance status 0 to 2
- Histologically proven epithelial carcinoma of ovary, fallopian tubes, or peritoneum, stage IIb to IVa
- Insufficient tumor response after three cycles of neoadjuvant carboplatin-paclitaxel chemotherapy
- Adequate blood counts: neutrophils > 1500/mm3, hemoglobin ≥ 9.0 g/dL, platelets > 100 G/L
- Adequate liver and kidney function: creatinine ≤ 1.5 times upper normal limit or GFR ≥ 60 mL/min/1.73 m2, bilirubin ≤ 1.5 times upper normal limit, ASAT/ALAT ≤ 1.5 times upper normal limit (≤ 5 times if liver metastases)
- No unstable medical conditions such as recent heart attack, unstable angina, active heart muscle disease, uncontrolled hypertension or psychiatric disorders
- Written informed consent given
- Affiliated with a social insurance plan or similar
You will not qualify if you...
- Extra-peritoneal metastases that make disease unresectable
- Signs of intestinal obstruction or risk of intestinal perforation
- Contraindications to carboplatin-paclitaxel chemotherapy such as allergy to paclitaxel
- Contraindications to PIPAC procedure including allergy to cisplatin or doxorubicin
- Heart failure or uncontrolled coronary disease
- Pregnancy or breastfeeding
- Being under legal guardianship or deprived of liberty
- Participation in other research with ongoing exclusion period
- Inability to attend medical follow-up due to geographic, social, or psychological reasons
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Trial Site Locations
Total: 6 locations
1
Hôpital Claude Huriez - Chirurgie générale et digestive
Lille, France
Actively Recruiting
2
Hôpital Claude Huriez - Oncologie médicale
Lille, France
Actively Recruiting
3
Hôpital de la Croix-Rousse
Lyon, France
Actively Recruiting
4
Hôpital Lyon Sud - Chirurgie Digestive et Oncologique
Pierre-Bénite, France, 69495
Actively Recruiting
5
Hôpital Lyon Sud - Chirurgie Gynécologique et oncologique-obstétrique
Pierre-Bénite, France
Actively Recruiting
6
Hôpital Lyon Sud - Oncologie Médicale
Pierre-Bénite, France
Actively Recruiting
Research Team
J
Justine ARQUILLIERE, MD
CONTACT
N
Naoual BAKRIN, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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