Ovarian Cancer
Conditions
Interventions
Trade Name: Nexavar
Product Name: Sorafenib
Pharmaceutical Form: Tablet
INN or Proposed INN: CARBOPLATIN
CAS Number: 41575944
Current Sponsor code: CARBOPLATIN
Other descriptive name: CARBOPLATIN
Conc
Sponsors
University of Bonn
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw the consent without the need to specify a respective reason o Histological confirmed primary epithelial ovarian cancer carcinoma of the fallopian tubes and extra ovarian peritoneal carcinoma stage FIGO IIIC or IV, verified by laparoscopy or laparotomy o More than 500 ml ascites (verified by ultrasound or ct-scan) o Female patients with age higher or equal to 18 years o Life expectancy of at least 12 weeks o Patients who have an ECOG performance status of less or equal 2 o Adequate bone marrow, renal and hepatic function, assessed by the following laboratory investigations at screening: o Hemoglobin = 8 g/dl o Absolute neutrophile count ? 1,500/ mm³ o Thrombocytes ? 100,000/ µl o Bilirubine total ? 1,5 x ULN o ALT and AST ? 2,5 x ULN o Alkaline phosphatase (AP) ? 6.0 x ULN o Serum creatinine ? 1,5 x ULN o Estimated GFR (by Jeliffe) ? 60 ml / min o Amylase and lipase ? 1.5 x ULN o PT or INR and PTT ? 1.5 x ULN Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: o Patients with a history of other malignancies during the past 3 years, with the exception of adequately treated basal or squamous-cell skin cancer, or cervical carcinoma o Major surgery within 4 weeks of enrolment, or major debulking surgery without any time limit o Patients with symptoms of ileus o Known history of HIV infection or chronic hepatitis B or C infection o Active serious bacterial or fungal infections (> grade 2 NCI-CTCAE, Version 3.0) o History of cardiac disease: congestive heart failure >NYHA class 2, active CAD (coronary artery disease) (MI more than 6 months prior to study entry is allowed); cardiac arrhythmia requiring and arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension o Patients undergoing renal dialysis o Patients with evidence or history of bleeding diathesis o History of motorial and sensorial neuropathic disorders equal or higher than grade 2 o Known neoplastic central nervous system abnormality. Patients with neurological symptoms should undergo CT scan/MRI of the brain to exclude brain metastasis o Manifest depression o Known or suspected allergy to the investigational agent or any agent given in association with this trial o Patients with seizure disorder requiring medication o History of organ allograft o Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study o Pregnant or breastfeeding patients: Women with childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of the study drug o Patients enrolled in this trial must use adequate barrier contraceptive measures during the course of the trial until hysterectomy in ‘Debulking surgery’ was performed o Any prior systemic anticancer therapy including chemotherapy, targeted agents, experimental therapy, endocrine therapy radiotherapy or biological therapy o Concurrent anticancer chemotherapy or immunotherapy. o Concurrent treatment with systemic corticosteroids, except antiemetic. o Investigational drug therapy outside of this trial during or within 4 weeks of study entry o Patients receiving immunotherapy, radiation therapy, chemotherapy, or other investigational agents within 30 days prior to the first study drug administration o Patients unable to swallow oral medications o Concomitant administration of: o Rifampicin o St. John´s Wort (hypericum perforatum; DE: Johanniskraut)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: progression free survival (PFS) between subjects treated with sorafenib in combination paclitaxel and carboplatin compared versus historic patient collective;Secondary Objective: • Evaluation of overall survival (OS) • Evaluation of Time to treatment failure (TTF) • Evaluation of response rates and duration of response • Evaluation of six and twelve month relapse rate post chemotherapy • Evaluation of quality of life (EORTC-QLQC30 / QLQ-OV28) • Evaluation of toxicity, safety and tolerability • Evaluation of tumor mass post surgery • Evaluation of ascites reduction pre surgery • Evaluation of biomarker (histological and peripheral) • Evaluation of tumor cell RNA expression, proteomic pattern • Evaluation of mineral metabolism;Primary end point(s): progression free survival (PFS) | — |
Countries
Germany
Outcome results
None listed