Phase 1Recruiting
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer (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
- Sponsor
- Hospices Civils de Lyon (Academic or other)
- Enrolment
- 15 planned
- Conditions
- Metastatic Ovarian Carcinoma; Peritoneal Carcinomatosis; Stage III Ovarian Cancer; Stage III Fallopian Tube Cancer; Metastatic Malignant Neoplasm in the Peritoneum; Stage IIb Ovarian Cancer; Stage IVa Ovarian Cancer; Stage IVa Fallopian Tube Cancer; Stage IIB Fallopian Tube Cancer
- Interventions
- Combined PIPAC / IV chemotherapy treatment
- Ages
- adults, older adults
- Registry
- NCT04811703, CTIS2024-515996-37-00
Full record on ClinicalTrials.gov
From the registry
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). Since the 7th amendment of the study, sodium thiosulfate as nephrtoxicity prevention has been administered concurrently with each PIPAC chemotherapy 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…
Primary outcomes
- Dose-limiting toxicities
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered