Actively Recruiting
Phase I Study of PIPAC with Cisplatin-Doxorubicin Combined with Systemic Chemotherapy in Women with Advanced Ovarian, Fallopian Tube, or Peritoneal Cancer Evaluating Safety and Recommended Dose After Insufficient Response to Carboplatin-Paclitaxel
Led by Hospices Civils de Lyon · Updated on 2026-05-22
15
Participants Needed
6
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying women with advanced ovarian, fallopian tube, or peritoneal epithelial cancer who have not had a strong enough tumor response after prior chemotherapy to allow complete surgical removal. This phase I trial aims to find the highest safe dose of a new chemotherapy delivered as a pressurized aerosol inside the abdomen (PIPAC) combined with standard intravenous chemotherapy. The study also looks at tumor response, changes in cancer spread, drug behavior in the body, and overall safety of this treatment approach. Participants will receive up to three 28-day treatment cycles. Each cycle includes a PIPAC procedure on Day 1 where doxorubicin and cisplatin are given at increasing doses, alongside standard carboplatin and paclitaxel chemotherapy on Day 8. Dose levels start low and increase based on patient tolerance, with protective sodium thiosulfate given from higher doses to reduce kidney risks. Treatment continues unless severe side effects occur. During the study, patients will have blood tests to measure drug levels and cancer markers, along with imaging scans to assess tumor changes. After treatment, those with tumor shrinkage or stable disease will be re-evaluated for possible surgery followed by recovery monitoring. Safety will be closely tracked throughout, including kidney function during the chemotherapy cycles. Participation lasts through treatment and post-operative follow-up if surgery is performed.
CONDITIONS
Brief 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...
- Female patients aged 18 to 75 years
- ECOG Performance Status of 0 to 2
- Histologically confirmed epithelial carcinoma of the ovary, fallopian tubes, or peritoneum, FIGO stage IIb to IVa
- Tumor response after three carboplatin-paclitaxel cycles is insufficient for complete cytoreductive surgery, confirmed by multidisciplinary review
- Adequate blood counts: neutrophils > 1,500/mm³, hemoglobin ≥ 9.0 g/dL, platelets > 100 × 10⁹/L
- Adequate kidney and liver function: creatinine ≤ 1.5× ULN or eGFR ≥ 60 mL/min/1.73 m², total bilirubin ≤ 1.5× ULN, AST and ALT ≤ 1.5× ULN (up to 5× ULN if liver metastases present)
- No unstable medical conditions that could worsen with study treatment or affect compliance
- Written informed consent provided
- Affiliation with a national health insurance system
You will not qualify if you...
- Presence of extra-peritoneal metastases preventing curative surgery
- Signs of bowel obstruction, lesions with high risk of intestinal perforation, or inflammatory bowel disease
- Contraindications to carboplatin-paclitaxel chemotherapy, including severe allergy to paclitaxel
- Contraindications to PIPAC, including allergy to cisplatin, doxorubicin, or related drugs
- Cardiac diseases such as myocardial insufficiency, uncontrolled coronary artery disease
- Known allergies to sodium thiosulfate, sulfites, or related excipients
- Live attenuated vaccine within 3 months before or planned during treatment
- Pregnancy or breastfeeding
- Legal protection status such as guardianship
- Participation in other interventional studies that may interfere
- Inability to comply with study follow-up due to geographic, social, or psychological reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive up to three 28-day cycles of combined chemotherapy. Each cycle includes a PIPAC session with cisplatin and doxorubicin on Day 1, followed by systemic carboplatin-paclitaxel chemotherapy on Day 8. Sodium thiosulfate may be administered prior to PIPAC from dose level 7 onward. Treatment continues every 4 weeks for up to three cycles unless unacceptable toxicity occurs.
3 treatment cycles with PIPAC on Day 1 and systemic chemotherapy on Day 8 of each cycle
Duration - Up to 8 months
Participants are monitored for safety, tumor response, and kidney function for up to 8 months after treatment completion.
Visits at 4 to 5 weeks after the third treatment cycle and additional safety monitoring visits
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
N
Naoual BAKRIN, MD
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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