multicenter italian study of the combination of bevacizumab and trabectedin with or without carboplatin in advanced ovarian cancer

Phase 1

• Conditions: adult women with platinum partially sensitive recurring ovarian cancer.; MedDRA version: 14.1Level: LLTClassification code 10033271Term: Ovarian neoplasiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003866-42-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-08
• Study Completion: 2018-03-15
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 71

Inclusion Criteria

­Age=18years ­ECOG-performance status 0-2 ­Cytological/histological diagnosis of epithelial ovarian cancer ­Progression free interval between 6-12 months (calculated from the first day of the last cycle of the previous last platinum-based chemotherapy until the date of progression confirmation through radiologic imaging). ­Only one previous platinum-based chemotherapy line ­Measurable disease according to RECIST version 1.1 ­Life expectancy = 12 weeks ­Patients must be able to receive dexamethasone or its equivalent, as a premedication for trabectedin ­Written informed consents given before the enrolment according to ICH/GCP.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

­Prior treatment with trabectedin ­Prior progression while on therapy containing bevacizumab or other VEGF pathway–target therapy ­Pre-existing grade > 1 sensitive/motor neurologic disorder ­Current or recent (within 30 days of first study dosing) treatment with another investigational drug ­Surgery (including open biopsy) within 4 weeks prior to the first planned dose of bevacizumab ­Current or recent (within 10 days prior to the first study drug dose) use of full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic purposes (except for line patency, in which case international normalized ratio [INR] must be maintained below 1.5). Post operative prophylaxis with low molecular weight heparin sc is allowed ­Inadequate bone marrow function: absolute neutrophil count (ANC): <1.5 x 109/l, or platelet count <100 x 109/l or haemoglobin <9 g/dl. Patients may be transfused to maintain haemoglobin values =9 g/dl ­Inadequate coagulation parameters: activated partial thromboplastin time (APTT) >1.5 x upper limit of normal (ULN) or INR >1.5 ­Inadequate liver function, defined as: serum (total) bilirubin > ULN for the institution AST/SGOT or ALT/SGPT >2.5 x ULN ­Inadequate renal function: serum creatinine >1.5 mg/dL or >132 ?mol/L and urine dipstick for proteinuria ?2+ and >1g of protein in their 24-hour urine collection ­History or evidence of brain metastases or spinal cord compression ­ Pregnant, breastfeeding women and women of child bearing potential, who do not agree to use a medically acceptable method of contraception through the treatment period and for 6 months after discontinuation of treatment ­History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular accident, stroke or transient ischemic attack or sub-arachnoid haemorrhage within 6 months prior to the first study treatment ­Uncontrolled hypertension (sustained systolic >150 mmHg and/or diastolic >100 mmHg despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease, including: myocardial infarction or unstable angina within 6 months prior to the first study treatment, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication ­History of bowel obstruction, including subocclusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction ­Non-healing wound, ulcer or bone fracture ­HCV positivity ­Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer

Study & Design

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