Clareo Health | Feasibility of the Combination of Chemotherapy (Carbo/Caelyx or Carbo/Doxorubicin) With Tocilizumab (mAb IL-6R) and Peg-Intron in Patients With Recurrent Ovarian Cancer
Feasibility of the Combination of Chemotherapy (Carbo/Caelyx or Carbo/Doxorubicin) With Tocilizumab (mAb IL-6R) and Peg-Intron in Patients With Recurrent Ovarian Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Leiden University Medical Center
With
University Medical Center Groningen
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically proven epithelial ovarian cancer
Progression of disease or relapse after previous therapy with platinum
Measurable disease (RECIST 1.1) or elevated CA125 \> 2 times the upper normal limit (UNL) within 3 months and confirmed
Age ≥18 years
WHO performance status 0-2
Adequate bone marrow function: WBC ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
Adequate liver function: bilirubin ≤1.5 x UNL range, ALAT and/or ASAT
* 2.5 x UNL (\<5x UNL in case of liver metastases), Alkaline Phosphatase ≤5 x UNL
Adequate renal function: the calculated creatinine clearance should be
* 50 mL/min
Survival expectation \> 3 months
Patients must be accessible for treatment and follow-up
Written informed consent according to the local Ethics Committee requirements
You may not be if
Chemotherapy within past 3 months
Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
Known hypersensitivity reaction to any of the components of the treatment
Pregnancy or lactating
Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
