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| Name | Class |
|---|---|
| Kom Op Tegen Kanker | OTHER |
| University Ghent | OTHER |
| Hopital Lariboisière | OTHER |
| University Women's Hospital Tübingen |
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The PIPAC nab-pac study is designed to examine the maximal tolerated dose of albumin bound nanoparticle paclitaxel (nab-pac, Abraxane) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a multicentre, multinational phase I trial.
Over 85% of women with ovarian cancer (OC) will develop a peritoneal recurrence after initial therapy. The prognosis of patients with recurrent disease is poor, with a median survival ranging from 12 to 24 months. Most of these patients ultimately develop platinum resistant disease (PROC). Current systemic therapy results in a very modest improvement of progression free and overall survival. The addition of locoregional, intraperitoneal (IP) therapy may improve disease control in recurrent OC. Recently, pressurized intraperitoneal aerosol therapy (PIPAC) was added to the therapeutic arsenal. This novel technique allows repeated laparoscopy aided aerosol delivery of anticancer drugs to the peritoneal cavity. Abraxane (nab-pac, Celgene) is a novel 130 nm, albumin-bound (nab) nanoparticle formulation of paclitaxel which has noteworthy single-agent activity and a favourable toxicity profile when used systemically in PROC. A recent phase I study showed a significant pharmacokinetic advantage after IP instillation of nab-pac in patients with peritoneal carcinomatosis from ovarian or gastro-intestinal (GI) origin.
In phase I of this study, dose escalation will be combined with pharmacokinetic/pharmacodynamic modelling which incorporates, in addition to plasma, tumour tissue, and peritoneal drug concentrations, biomarkers of toxicity and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abraxane 35 mg/m² | Experimental | PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles. |
|
| Abraxane 70 mg/m² | Experimental | PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles. |
|
| Abraxane 90 mg/m² | Experimental | PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles. |
|
| Abraxane 112.5 mg/m² | Experimental | PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. |
|
| Abraxane 140 mg/m² | Experimental | PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIPAC with Abraxane | Drug | Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximally Tolerated Dose (MTD) of Abraxane | The MTD was defined as the highest dose of aerosolized Abraxane, administered 3 times using PIPAC, that does not cause unacceptable side effects. Dose limiting toxicity was recorded in a 14 week-window starting from the first PIPAC and defined a priori as any of the following: 1. any Grade 3 or 4 non-hematologic toxicity excluding fatigue and controllable nausea, vomiting, abdominal pain, and diarrhoea; 2. grade 4 thrombocytopenia; 3. grade 4 neutropenia lasting more than 7 days or associated with fever; 4. failure to perform more than one PIPAC due to toxicity; 5. surgical complication Dindo-Clavien grade IIIB or higher. In order to optimize the balance between safety and efficacy, we used a time-to-event continual reassessment model (TITE-CRM), where an initial design was followed until the first DLT occurred. Conservative a priori estimates of DLT were used to calculate the original dose escalation scheme. | Within 14 weeks of the start of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Morbidity | Surgical complications were scored using the Clavien Dindo classification. Grade I: Any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention. This includes the need for certain drugs (e.g. antiemetics, antipyretics, analgesics, diuretics and electrolytes), treatment with physiotherapy and wound infections that are opened at the bedside Grade II: Complications requiring drug treatments other than those allowed for Grade I complications; this includes blood transfusion and total parenteral nutrition (TPN) Grade III: Complications requiring surgical, endoscopic or radiological intervention Grade IV: Life-threatening complications; this includes CNS complications (e.g. brain haemorrhage, ischaemic stroke, subarachnoid haemorrhage) which require intensive care, but excludes transient ischaemic attacks (TIAs) Grade V: Death of the patient |
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Inclusion Criteria:
Phase I study: patients with advanced carcinomatosis from ovarian, breast, gastric, or pancreatic origin. No alternative systemic treatment options are available.
Age over 18 years
Adequate performance status (Karnofsky index > 60%)
Absence of intestinal or urinary obstruction
Limited size of the majority of peritoneal tumor implants (< 5 mm)
Absent or limited ascites
Ability to understand the proposed treatment protocol and provide informed consent
Expected life expectancy more than 6 months
Laboratory data
Absence of alcohol and/or drug abuse
No other concurrent malignant disease
Written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wim P Ceelen, MD, PhD, Prof | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Ghent | Ghent | East-Flanders | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30911657 | Background | Van De Sande L, Graversen M, Hubner M, Pocard M, Reymond M, Vaira M, Cosyns S, Willaert W, Ceelen W. Intraperitoneal aerosolization of albumin-stabilized paclitaxel nanoparticles (Abraxane) for peritoneal carcinomatosis - a phase I first-in-human study. Pleura Peritoneum. 2018 Jun 8;3(2):20180112. doi: 10.1515/pp-2018-0112. eCollection 2018 Jun 1. | |
| 35843174 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Abraxane 35 mg/m² | PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2018 |
Not provided
| OTHER |
| Candiolo Cancer Institute - IRCCS | OTHER |
| Centre Hospitalier Universitaire Vaudois | OTHER |
Not provided
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| 6 months after third PIPAC |
| Maximum Plasma Concentration of Abraxane | Abraxane will be measured in plasma, using UPLC-MS/MS. | T = 0 minutes, T = 15 minutes, T = 30 minutes, T = 60 minutes, T = 1.5 hour, T = 2 hours, T = 4 hours, T = 8 hours, T = 12 hours, T = 24 hours |
| Area Under The Curve (AUC) of Abraxane | Abraxane will be measured in plasma, using LC-MS/MS. | T = 0 minutes, T = 15 minutes, T = 30 minutes, T = 60 minutes, T = 1.5 hour, T = 2 hours, T = 4 hours, T = 8 hours, T = 12 hours, T = 24 hours |
| Histological Response Via Peritoneal Regression Grading Scoring (PRGS) | Punch biopsies are taken at the same location, which are marked with a stainless-steel surgical clip during each PIPAC procedure. Samples are fixed in 4% paraformaldehyde in PBS for 72 hours and embedded in paraffin. Tissues are serially sectioned and stained with haematoxylin & eosin; immunohistochemical staining is performed for epithelial cellular adhesion molecule (EpCAM). The peritoneal regression grading score (PRGS) is determined by a GI pathologist. The mean score of all samples is calculated per treatment, and percentage changes in mean PRGS between successive PIPAC treatments is calculated. The unit of measure represented is the amount of participants in which tumor regression was observed. | T = 0 minutes, before nebulization |
| Neutropenia - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Blood samples will be collected to analyse the absolute neutrophil count | Pre-operatively, and 12 hours, 24 hours and 1 week after each PIPAC |
| Decreased Platelets - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Blood samples will be collected to analyse the amount of platelets. | Pre-operatively, and 12 hours, 24 hours and 1 week after each PIPAC |
| Ceelen W, Sandra L, de Sande LV, Graversen M, Mortensen MB, Vermeulen A, Gasthuys E, Reynders D, Cosyns S, Hoorens A, Willaert W. Phase I study of intraperitoneal aerosolized nanoparticle albumin based paclitaxel (NAB-PTX) for unresectable peritoneal metastases. EBioMedicine. 2022 Aug;82:104151. doi: 10.1016/j.ebiom.2022.104151. Epub 2022 Jul 15. |
| FG001 |
| Abraxane 70 mg/m² |
PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| FG002 | Abraxane 90 mg/m² | PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| FG003 | Abraxane 112.5 mg/m² | PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| FG004 | Abraxane 140 mg/m² | PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Abraxane 35 mg/m² | PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| BG001 | Abraxane 70 mg/m² | PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| BG002 | Abraxane 90 mg/m² | PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| BG003 | Abraxane 112.5 mg/m² | PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| BG004 | Abraxane 140 mg/m² | PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Age, Continuous | Median | Full Range | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximally Tolerated Dose (MTD) of Abraxane | The MTD was defined as the highest dose of aerosolized Abraxane, administered 3 times using PIPAC, that does not cause unacceptable side effects. Dose limiting toxicity was recorded in a 14 week-window starting from the first PIPAC and defined a priori as any of the following: 1. any Grade 3 or 4 non-hematologic toxicity excluding fatigue and controllable nausea, vomiting, abdominal pain, and diarrhoea; 2. grade 4 thrombocytopenia; 3. grade 4 neutropenia lasting more than 7 days or associated with fever; 4. failure to perform more than one PIPAC due to toxicity; 5. surgical complication Dindo-Clavien grade IIIB or higher. In order to optimize the balance between safety and efficacy, we used a time-to-event continual reassessment model (TITE-CRM), where an initial design was followed until the first DLT occurred. Conservative a priori estimates of DLT were used to calculate the original dose escalation scheme. | Posted | Count of Participants | Participants | Within 14 weeks of the start of the treatment |
|
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Surgical Morbidity | Surgical complications were scored using the Clavien Dindo classification. Grade I: Any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention. This includes the need for certain drugs (e.g. antiemetics, antipyretics, analgesics, diuretics and electrolytes), treatment with physiotherapy and wound infections that are opened at the bedside Grade II: Complications requiring drug treatments other than those allowed for Grade I complications; this includes blood transfusion and total parenteral nutrition (TPN) Grade III: Complications requiring surgical, endoscopic or radiological intervention Grade IV: Life-threatening complications; this includes CNS complications (e.g. brain haemorrhage, ischaemic stroke, subarachnoid haemorrhage) which require intensive care, but excludes transient ischaemic attacks (TIAs) Grade V: Death of the patient | Posted | Number | participants | 6 months after third PIPAC |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration of Abraxane | Abraxane will be measured in plasma, using UPLC-MS/MS. | Posted | Mean | Standard Deviation | ng/mL | T = 0 minutes, T = 15 minutes, T = 30 minutes, T = 60 minutes, T = 1.5 hour, T = 2 hours, T = 4 hours, T = 8 hours, T = 12 hours, T = 24 hours |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under The Curve (AUC) of Abraxane | Abraxane will be measured in plasma, using LC-MS/MS. | Posted | Mean | Standard Deviation | h*ng/mL | T = 0 minutes, T = 15 minutes, T = 30 minutes, T = 60 minutes, T = 1.5 hour, T = 2 hours, T = 4 hours, T = 8 hours, T = 12 hours, T = 24 hours |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Histological Response Via Peritoneal Regression Grading Scoring (PRGS) | Punch biopsies are taken at the same location, which are marked with a stainless-steel surgical clip during each PIPAC procedure. Samples are fixed in 4% paraformaldehyde in PBS for 72 hours and embedded in paraffin. Tissues are serially sectioned and stained with haematoxylin & eosin; immunohistochemical staining is performed for epithelial cellular adhesion molecule (EpCAM). The peritoneal regression grading score (PRGS) is determined by a GI pathologist. The mean score of all samples is calculated per treatment, and percentage changes in mean PRGS between successive PIPAC treatments is calculated. The unit of measure represented is the amount of participants in which tumor regression was observed. | Tumour tissue samples were taken from each abdominal quadrant (n = 4) before aerosol delivery. In 30% of all procedures, less than four biopsies (or none) were taken due to technical reasons (adhesions) or because no visible tumour was present, which explains the lower number of participants analyzed. | Posted | Number | participants with tumor regression | T = 0 minutes, before nebulization |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Neutropenia - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Blood samples will be collected to analyse the absolute neutrophil count | Posted | Count of Participants | Participants | Pre-operatively, and 12 hours, 24 hours and 1 week after each PIPAC |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Decreased Platelets - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Blood samples will be collected to analyse the amount of platelets. | Posted | Count of Participants | Participants | Pre-operatively, and 12 hours, 24 hours and 1 week after each PIPAC |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abraxane 35 mg/m² | PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. | 1 | 2 | 2 | 2 | 2 | 2 |
| EG001 | Abraxane 70 mg/m² | PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. | 2 | 2 | 2 | 2 | 2 | 2 |
| EG002 | Abraxane 90 mg/m² | PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. | 1 | 3 | 2 | 3 | 3 | 3 |
| EG003 | Abraxane 112.5 mg/m² | PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG004 | Abraxane 140 mg/m² | PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. | 1 | 10 | 6 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| intestine obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| thrombocytopenia grade 3 (CTCAE) | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| progression peritoneal disease leading to death | General disorders | Non-systematic Assessment |
| ||
| surgical wound infection | Surgical and medical procedures | Non-systematic Assessment |
| ||
| anaphylactic shock during surgery | Surgical and medical procedures | Non-systematic Assessment |
| ||
| infection peritoneum | Infections and infestations | Non-systematic Assessment |
| ||
| anorexia | General disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| thrombopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| white blood cell decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| elevated AST | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| elevated ALT | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| elevated ALP | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| elevated bilirubin | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| elevated GGT | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hypernatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| bleeding at incision | Surgical and medical procedures | Non-systematic Assessment |
| ||
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| adhesions | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| paralytic ileus | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| electrocardiogram T wave abnormal | Cardiac disorders | Non-systematic Assessment |
| ||
| bacterial pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| skin infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| surgical wound infection | Surgical and medical procedures | Non-systematic Assessment |
| ||
| peritoneal infection | Infections and infestations | Non-systematic Assessment |
| ||
| alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| edema lower limbs | General disorders | Non-systematic Assessment |
| ||
| peripheral sensory neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| allergic reaction to anesthesia | Immune system disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof | Ghent University | +32(0)93326251 | wim.ceelen@ugent.be |
| Dec 24, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D010182 | Pancreatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
|
|
|
|
| OG002 | Abraxane 90 mg/m² | PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| OG003 | Abraxane 112.5 mg/m² | PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| OG004 | Abraxane 140 mg/m² | PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
|
|
| OG003 | Abraxane 112.5 mg/m² | PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| OG004 | Abraxane 140 mg/m² | PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
|
|
| OG003 | Abraxane 112.5 mg/m² | PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| OG004 | Abraxane 140 mg/m² | PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
|
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PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| OG002 | Abraxane 90 mg/m² | PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| OG003 | Abraxane 112.5 mg/m² | PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| OG004 | Abraxane 140 mg/m² | PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
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| OG003 | Abraxane 112.5 mg/m² | PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| OG004 | Abraxane 140 mg/m² | PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
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| OG003 | Abraxane 112.5 mg/m² | PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
| OG004 | Abraxane 140 mg/m² | PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles. |
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