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New treatment option for Metastatic Ovarian Carcinoma
Official title Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer
ClinicalTrials.gov ID: NCT04811703
What this study is testing
What is Combined PIPAC / IV chemotherapy treatment?
Combined PIPAC / IV chemotherapy treatment is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic ovarian carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Women with a history of tumor response insufficient to allow complete cytoreductive surgery after three cycles of prior neoadjuvant systemic carboplatin-paclitaxel chemotherapy will be prospectively enrolled in this phase I study. After providing written informed consent and confirmation of unresectable disease by multidisciplinary assessment, patients will undergo three cycles of combined chemotherapy consisting of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with doxorubicin and cisplatin at escalating dose levels, combined with systemic intravenous chemotherapy using carboplatin and paclitaxel at standard doses.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Age ≥ 18 years and ≤ 75 years;
- ECOG Performance Status 0-2;
- Histologically confirmed epithelial carcinoma of the ovary, fallopian tubes, or peritoneum, FIGO stage IIb to IVa, with a tumor response after three...
- Adequate hematological function:
- Absolute neutrophil count \> 1,500/mm³ (or 1.5 × 10⁹/L);
You likely can't join if
- Extra-peritoneal metastases whose location or extent precludes a potentially curative surgical procedure;
- Signs of bowel obstruction, bowel lesions with a high risk of intestinal perforation based on their location, or evidence of inflammatory bowel...
- Contraindication to intravenous carboplatin-paclitaxel chemotherapy, including known severe hypersensitivity to paclitaxel;
- Contraindication to PIPAC procedures, including:
- Known hypersensitivity to cisplatin or other platinum compounds;
- Known hypersensitivity to doxorubicin or other anthracyclines or anthracenediones;
See the full eligibility criteria
- Age ≥ 18 years and ≤ 75 years;
- ECOG Performance Status 0-2;
- Histologically confirmed epithelial carcinoma of the ovary, fallopian tubes, or peritoneum, FIGO stage IIb to IVa, with a tumor response after three cycles of carboplatin-paclitaxel that does not correspond to disease...
- Adequate hematological function:
- Absolute neutrophil count \> 1,500/mm³ (or 1.5 × 10⁹/L);
- Hemoglobin ≥ 9.0 g/dL;
- Platelet count \> 100 × 10⁹/L;
- Adequate renal and hepatic function:
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or estimated glomerular filtration rate ≥ 60 mL/min/1.73 m² (CKD-EPI equation);
- Total bilirubin ≤ 1.5 × ULN;
- AST and ALT ≤ 1.5 × ULN (≤ 5 × ULN in patients with liver metastases);
- No unstable medical conditions, including myocardial infarction within 6 months prior to study entry, congestive heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, uncontrolled hypertension...
- Written informed consent obtained prior to any study-specific procedures;
- Patient affiliated with a national health insurance system.
- Extra-peritoneal metastases whose location or extent precludes a potentially curative surgical procedure;
- Signs of bowel obstruction, bowel lesions with a high risk of intestinal perforation based on their location, or evidence of inflammatory bowel disease;
- Contraindication to intravenous carboplatin-paclitaxel chemotherapy, including known severe hypersensitivity to paclitaxel;
- Contraindication to PIPAC procedures, including:
- Known hypersensitivity to cisplatin or other platinum compounds;
- Known hypersensitivity to doxorubicin or other anthracyclines or anthracenediones;
- Cardiac disease with myocardial insufficiency;
- Uncontrolled coronary artery disease;
- Known hypersensitivity to sodium thiosulfate, sulfites, or any of its excipients;
- Administration of a live attenuated vaccine within 3 months prior to study treatment initiation or planned during the study;
- Pregnant or breastfeeding women;
- Individuals deprived of liberty, under guardianship, or subject to legal protection measures;
- Participation in another treatment research study with an ongoing exclusion period at inclusion, or in a study that could interfere with the results of the present study, as judged by the investigator;
- Inability to comply with study follow-up for geographical, social, or psychological reasons, as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
- Lyon, France
- Pierre-Bénite, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France; Lyon, France; Pierre-Bénite, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.