Chemo-Immunotherapy: Observational Trial of Carboplatin-pegylated Liposomal Doxorubicin (PLD) or Doxorubicin Combination Chemotherapy With Tocilizumab, a Humanized Monoclonal Antibody Against the Human Interleukin-6 (IL-6) Receptor, and Pegylated Interferon Alpha (Peg-Intron) for Patients With Recurrent Ovarian Cancer.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Infection with tuberculosis and hepatitis B or C