Prospective, open label, multi center phase II clinical trial with neoadjuvant chemotherapy in addition with Sorafenib in patients with primarily advanced ovarian cancer (FIGO IIIC + IV) and ascites (>500ml) - primofenib-07

• Conditions: Stage FIGO IIIc and IV with more than 500 ml ascites; MedDRA version: 9.1Level: LLTClassification code 10057529Term: Ovarian cancer metastatic; Ovarian Cancer

• Registration Number: EUCTR2006-004644-24-DE
• Lead Sponsor: niversity of Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-13
• Last Update Posted: 6 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

oWritten 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
oHistological 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
oMore than 500 ml ascites (verified by ultrasound or ct-scan)
oFemale patients with age higher or equal to 18 years
oLife expectancy of at least 12 weeks
oPatients who have an ECOG performance status of less or equal 2
oAdequate bone marrow, renal and hepatic function, assessed by the following laboratory investigations at screening:
oHemoglobin = 8 g/dl
oAbsolute neutrophile count ? 1,500/ mm³
oThrombocytes? 100,000/ µl
oBilirubine total? 1,5 x ULN
oALT and AST? 2,5 x ULN
oAlkaline phosphatase (AP)? 6.0 x ULN
oSerum creatinine? 1,5 x ULN
oEstimated GFR (by Jeliffe)? 60 ml / min
oAmylase and lipase? 1.5 x ULN
oPT 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

oPatients 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
oMajor surgery within 4 weeks of enrolment, or major debulking surgery without any time limit
oPatients with symptoms of ileus
oKnown history of HIV infection or chronic hepatitis B or C infection
oActive serious bacterial or fungal infections (> grade 2 NCI-CTCAE, Version 3.0)
oHistory 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
oPatients undergoing renal dialysis
oPatients with evidence or history of bleeding diathesis
oHistory of motorial and sensorial neuropathic disorders equal or higher than grade 2
oKnown neoplastic central nervous system abnormality. Patients with neurological symptoms should undergo CT scan/MRI of the brain to exclude brain metastasis
oManifest depression
oKnown or suspected allergy to the investigational agent or any agent given in association with this trial
oPatients with seizure disorder requiring medication
oHistory of organ allograft
oSubstance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study
oPregnant 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
oPatients enrolled in this trial must use adequate barrier contraceptive measures during the course of the trial until hysterectomy in ‘Debulking surgery’ was performed
oAny prior systemic anticancer therapy including chemotherapy, targeted agents, experimental therapy, endocrine therapy radiotherapy or biological therapy
oConcurrent anticancer chemotherapy or immunotherapy.
oConcurrent treatment with systemic corticosteroids, except antiemetic.
oInvestigational drug therapy outside of this trial during or within 4 weeks of study entry
oPatients receiving immunotherapy, radiation therapy, chemotherapy, or other investigational agents within 30 days prior to the first study drug administration
oPatients unable to swallow oral medications
oConcomitant administration of:
oRifampicin
oSt. John´s Wort (hypericum perforatum; DE: Johanniskraut)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>•Evaluation of Time to treatment failure (TTF)<br>•Evaluation of response rates and duration of response <br>•Evaluation of six and twelve month relapse rate post chemotherapy<br>•Evaluation of quality of life (EORTC-QLQC30 / QLQ-OV28)<br>•Evaluation of toxicity, safety and tolerability<br>•Evaluation of tumor mass post surgery<br>•Evaluation of ascites reduction pre surgery<br>•Evaluation of biomarker (histological and peripheral) <br>•Evaluation of tumor cell RNA expression, proteomic pattern<br>•Evaluation of mineral metabolism;Primary end point(s): progression free survival (PFS)