Neoplasms

Symptoms and General Pathology

All Conditions

Wounds and Injuries

Digestive System Diseases

Behaviors and Mental Disorders

Neoplasm Metastasis

Hyperthermia

Fever

Peritoneal Neoplasms

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Cardiotonic Agents

Dopamine

Basal infusion of crystalloids (normal saline,Ringer's lactate,Ringer's solution) at 4 ml/kg/h and boluses of colloids (HES 130/0.4 ) for values of cardiac index (CI) \<2.5 l/min/m2, stroke volume index (SVI) \< 35 SVI ml/m2 and stroke volume variation (SVV)\> 15%. In the case of CI \<2.5 l/min/m2 and SVI \<35 ml/m2 with SVV \< 15%, an infusion with dopamine was initiated.

Goal Directed Intravenous Restrictive Fluid Therapy

Basal infusion of crystalloid (normal saline,Ringer's lactate,Ringer's solution)variable from 4 to 12 ml/kg/hour.

Conventional Intravenous Fluid therapy

Ester Forastiere, M.D.

The aim of the study is to assess whether in cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) the use of a protocol of intravenous fluid therapy combined with goal directed fluid therapy (GDT) is associated with a significant change in morbidity, length of hospital stay and mortality compared to a standard fluid therapy. Patients undergoing CRS and hipec are randomly divided into two treatment groups. The GDT group receive fluid intravenous therapy according to a specific treatment protocol guided by monitored hemodynamic parameters assessed using the arterial pressure signal monitoring to assess stroke volume and cardiac output via an automated pulse contour analysis (Flotrac/Vigileo®); the control group receive the standard fluid therapy (crystalloid and colloid). Fluid therapy regimen is free in the control group and targeted in the GDT group. In both groups, the investigators evaluate the incidence of major abdominal and systemic complications, the total duration of hospital stay, mortality, the total amount of fluids administered, their breakdown (crystalloid/colloid) and the total number of colloid boluses administered.

Goal Directed Therapy (GDT) in Cytoreductive Surgery (CRS) and Hyperthermic Intra Peritoneal Chemotherapy (Hipec)

Cytoreductive Surgery With Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) - Goal Directed Therapy vs. Standard Fluid Therapy. Prospective Randomized Study

Regina Elena Cancer Institute

M.D., Chief of Critical Area Department

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

Anti-Infective Agents

Antibodies

Antibodies, Monoclonal

Gemcitabine

Paclitaxel

Carboplatin

Doxorubicin

Liposomal doxorubicin

Albumin-Bound Paclitaxel

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Groups of subjects will receive a weekly infusions of KHK2866 as treatment for advanced cancer. If there no severe side effects, the dose will be increased for future subjects. A total of four groups are anticipated. Once an acceptable dose is determined an additional seven subjects will be treated at that dose.

Open to subjects with ovarian, fallopian tube, or primary peritoneal cancer only.

One group of subjects will receive one dose below the maximum tolerated dose of KHK2866 identified in Phase 1a along with gemcitabine and carboplatin. The dose of KHK2866 will be increased to the MTD for the next group if no severe side effects are noted. Once an acceptable dose is determined an additional seven subjects will be treated at that dose.

Open to subjects with ovarian, fallopian tube, or primary peritoneal cancer only.

One group of subjects will receive one dose below the maximum tolerated dose of KHK2866 identified in Phase 1a along with weekly paclitaxel (80 mg/m2). The dose of KHK2866 will be increased to the MTD for the next group if no severe side effects are noted. Once an acceptable dose is determined an additional seven subjects will be treated at that dose.

Open to subjects with ovarian, fallopian tube, or primary peritoneal cancer only.

One group of subjects will receive one dose below the maximum tolerated dose of KHK2866 identified in Phase 1a along with monthly PLD (40 mg/m2). The dose of KHK2866 will be increased to the MTD for the next group if no severe side effects are noted. Once an acceptable dose is determined an additional seven subjects will be treated at that dose.

Potentially therapeutic monoclonal antibody for the treatment of advanced cancer and ovarian cancer.

KHK2866

Combination chemotherapy with KHK2866 to treat advanced platinum-sensitive ovarian cancer. Gemcitabine dose 1000 mg/m2, Carboplatin dose AUC=4

Gemcitabine and Carboplatin

Combination chemotherapy with KHK2866 to treat advanced platinum-resistant ovarian cancer. Paclitaxel will be administered weekly at a dose of 80 mg/m2.

paclitaxel

Combination chemotherapy with KHK2866 to treat advanced platinum-resistant ovarian cancer. PLD will be administered weekly at a dose of 40 mg/m2.

pegylated liposomal doxorubicin

Bruce A Silver, M.D.

This is a two-part, Phase 1, open-label, multicenter, dose escalation study of KHK2866 as monotherapy in patients with advanced solid tumors, and in combination with chemotherapy in subjects platinum-sensitive and platinum-resistant ovarian cancer.

During Phase 1a, groups of eligible patients with advanced solid tumors will receive KHK2866 as monotherapy in escalating doses. The Phase 1b portion will enroll patients with ovarian cancer who will receive KHK2866 in combination with one of three chemotherapy regimens (Arms): gemcitabine+carboplatin (platinum-sensitive, weekly paclitaxel (platinum-resistant), or pegylated liposomal doxorubicin (platinum-resistant). Escalating doses of the combination of KHK2866 and the chemotherapy regimen will given to two groups of subjects per Arm. The goal of the study is to learn about the side effects of KHK2866 alone or given in combination with chemotherapy. All subjects will receive study therapy for up to 6 cycles (up to 12 cycles for subjects assigned to PLD \[Arm 3 of Phase 1b\]), or until disease progression, the development of severe side effects, noncompliance or withdrawal of consent by the subject, or other removal criteria whichever comes first.

Study of Anti-HB-EGF Antibody KHK2866 in Subjects With Advanced Solid Tumors and Ovarian Cancer

Phase 1 Study of Anti-HB-EGF Monoclonal Antibody KHK2866 as Monotherapy in Subjects With Advanced Solid Tumors and in Combination With Chemotherapy in Ovarian Cancer

The safety of KHK2866 will be determined by reported adverse events (AEs), changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations, and treatment discontinuation due to toxicity.

Participants will have serial blood samples taken to determine the PK profile of the study drug.

Participants will have serial blood samples taken to develop the PD profile.

Participants will have serial blood samples to check for the development of anti-KHK2866 antibodies.

Kyowa Hakko Kirin Pharma, Inc.

Kyowa Kirin Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Goal Directed Therapy (GDT) in Cytoreductive Surgery (CRS) and Hyperthermic Intra Peritoneal Chemotherapy (Hipec)	NCT01882920	Primary Periton... Secondary Perit...	Goal Directed I... Conventional In...	18 Years -	Regina Elena Cancer Institute
Study of Anti-HB-EGF Antibody KHK2866 in Subjects With Advanced Solid Tumors and Ovarian Cancer	NCT01279291	Neoplasms Ovarian Neoplas... Fallopian Tube ... Primary Periton...	KHK2866 Gemcitabine and... paclitaxel pegylated lipos...	18 Years -	Kyowa Kirin Co., Ltd.

Spots Global Cancer Trial Database for primary peritoneal neoplasm