Safety and Pharmacokinetics of Intraoperative Hyperthermic Intraperitoneal Chemoperfusion (HIPEC)...
Ovarian CancerThe purpose of this phase I study is to determine the safety, feasibility, maximum tolerated dose (MTD), pharmacokinetics and pharmacodynamics of Cisplatin administered as Intraoperative Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients with Platinum-Sensitive Recurrent Ovarian Cancer.
Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) in Ovarian Cancer Recurrence
First Recurrence of Ovarian CancerThe purpose of this study is to determine the role of surgery followed by hyperthermic intra-peritoneal chemotherapy (HIPEC) versus surgery alone in patients with platinum-sensitive first recurrence of ovarian cancer. Moreover it is a prospective randomized multicenter trial, aimed to investigate the prognostic role of surgery plus HIPEC versus surgery alone in terms of progression free interval, overall survival, morbidity and mortality, second recurrence pattern, quality of life with EORTC QLQ-C30 and QLQ OV28 questionnaires.
Trial of Autologous, Hapten-Modified Vaccine, OVAX, in Patients With Relapsed Stage III or IV Ovarian...
Adenocarcinoma of the OvaryTo determine if a vaccine made from the patient's own tumor tissue can stimulate an immune response against the patient's tumor cells. To determine the safety of the vaccine.
Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With...
Ovarian CancerRATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.
Paclitaxel and Cisplatin as First-Line Treatment for Patients With Stage I, Stage II, Stage III,...
Ovarian CancerRATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving paclitaxel together with cisplatin as first-line therapy and to see how well it works in treating patients with stage I, stage II, stage III, or stage IV ovarian epithelial cancer.
An RCT of Concurrent and Maintenance Cediranib in Women With Platinum-sensitive Relapsed Ovarian...
Ovarian CancerThe purpose of this study is to assess the safety and efficacy of cediranib in combination with standard chemotherapy, in patients who have relapsed with ovarian, fallopian tube or epithelial cancer, after first line platinum based treatment.
A Phase I/II Study of Paclitaxel Plus Carboplatin Plus Vorinostat in Recurrent Ovarian Cancer
Ovarian CancerTITLE:A Phase II non-comparative study of paclitaxel plus carboplatin in combination with Vorinostat in patients with advanced, recurrent epithelial ovarian cancer. INDICATION:Second-line treatment of patients with recurrent platinum-sensitive epithelial ovarian cancer. RATIONALE:Recurrent epithelial ovarian cancer is today an incurable disease. The current standard of care consists of systemic chemotherapy using either carboplatin plus paclitaxel (in platinum-sensitive patients) or single agent chemotherapy with agents like liposomal doxorubicin, topotecan, weekly paclitaxel or gemcitabine (platinum non-sensitive patients). The outcome for patients with advanced ovarian cancer nevertheless remains poor.Preclinical evidence suggests that vorinostat, a potent histone deacetylase (HDAC) inhibitor, may potentiate the antitumor activity of paclitaxel and/or carboplatin. The study will assess whether the addition of vorinostat to paclitaxel plus carboplatin is manageable and induces reasonable response rates in patients with advanced recurrent, platinum-sensitive ovarian cancer. Biomarkers will be collected from both primary tumors and biopsies before and after start of treatment with vorinostat. DESIGN:Phase II, single-center study. All eligible patients will be treated with intravenous paclitaxel plus carboplatin plus oral vorinostat. Patients will be treated with a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal of consent. Clinical endpoints will include adverse experiences, progression-free survival (PFS) and response rate (RR). SAMPLE:Patients must have a histologically confirmed diagnosis of epithelial ovarian cancer, cancer of the Fallopian tube or primary peritoneal adenocarcinoma. All patients will have received first-line therapy with carboplatin plus paclitaxel. Patients should be platinum sensitive, defined as recurrence or progression of ovarian cancer, cancer of the Fallopian tubes or primary peritoneal adenocarcinoma 6 months or later after the end of first-line chemotherapy. Patients to be enrolled on this study must have acceptable performance status and acceptable renal and hepatic function, and be free of other serious intercurrent illness that could impair their ability to receive protocol therapy. The study will include up to 55 assessable patients, of which 20 will provide biomarkers. It is estimated that the inclusion period will last approximately 24 months. DOSAGE/DOSAGE FORM, ROUTE, AND DOSE REGIMEN Eligible patients will be treated with paclitaxel (175 mg/m2) and carboplatin AUC5 administered by intravenous infusion (IV) on day 1 of each treatment cycle. In addition, all eligible patients will receive treatment with oral vorinostat (400 mg) administered once daily by mouth with food on days -4 through 10 of Cycle 1 (25-day treatment cycle) and days 1 through 14 of each subsequent 21-day treatment cycle. Patients will receive antiemetic therapy according to institutional guidelines as well as premedication with dexamethasone, and antihistamines (an H1-receptor antagonist and an H2-receptor antagonist) for prevention of the side effects of paclitaxel.
MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
Ovarian CancerThe goal of this clinical trial is to study the feasibility and efficacy of anti-MESO antigen receptors (CARs) T cell therapy for relapsed and refractory ovarian cancer.
Reprab Study: PLD + Trabectedin Rechallenge
Relapsed Ovarian CancerRECHALLENGE WITH PEGYLATED LIPOSOMAL DOXORUBICIN ADDED TO TRABECTEDIN IN RECURRENT OVARIAN CANCER: A MULTICENTER, PROSPECTIVE TRIAL
A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal...
Epithelial Ovarian CancerFallopian Tube Cancer1 moreThis phase II clinical trial studies the safety and effect of Gimatecan in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or peritoneal cancer. The chemotherapy will be given every four weeks.This study is a single-arm, multi-center research design.