Peritoneal Carcinomatosis Clinical Trial
Official title:
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
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04826432 -
Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis
|
Phase 2 | |
| Recruiting |
NCT03127774 -
Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma
|
Phase 2 | |
| Recruiting |
NCT04024917 -
Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis
|
N/A | |
| Active, not recruiting |
NCT03508570 -
Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis
|
Phase 1 | |
| Not yet recruiting |
NCT04352894 -
Intraoperative ICG Fluorescence Imaging for Peritoneal Carcinomatosis Detection
|
N/A | |
| Completed |
NCT05547568 -
A Nomogram to Predict Major Postoperative Complications After Cytoreductive Surgery and HIPEC Based on Pre and Peroperative Criteria: Which Patient Require Intensive Monitoring?
|
||
| Completed |
NCT06318793 -
Preoperative Inflammatory Markers Predict Postoperative Complications After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Colorectal Carcinomatosis
|
||
| Terminated |
NCT01683864 -
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04547725 -
Complete Cytoreduction Followed by IP and Systemic Chemotherapies for Gastric Cancer With Peritoneal Carcinomatosis
|
N/A | |
| Completed |
NCT03304210 -
PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
|
Phase 1 | |
| Withdrawn |
NCT03682744 -
CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)
|
Phase 1 | |
| Terminated |
NCT04047771 -
A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis
|
Phase 1 | |
| Recruiting |
NCT05623787 -
Diagnostic Value of Diffusion-weighted Magnetic Resonance in High-risk Colorectal and Appendiceal Neoplasms
|
N/A | |
| Recruiting |
NCT05063019 -
Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index
|
N/A | |
| Completed |
NCT02891447 -
Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer
|
Phase 2 | |
| Recruiting |
NCT04231175 -
Dedicated MR Imaging vs Surgical Staging of Peritoneal Carcinomatosis in Colorectal Cancer
|
N/A | |
| Not yet recruiting |
NCT04734691 -
Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study
|
Phase 2 | |
| Recruiting |
NCT04108936 -
Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses
|
||
| Completed |
NCT02604784 -
Study of Efficacy and Safety of Laparoscopic Intra-abdominal Chemotherapy (PIPAC) Performed in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancer and Primary Peritoneal Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT01764789 -
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer
|
N/A |