Recurrent platinum resistant, p53 positive ovarian cancer. MedDRA version: 12.1 Level: LLT Classification code 10066697 Term: Ovarian cancer recurrent
Conditions
Interventions
Trade Name: Gemcitabine
Product Name: Gemzar
Product Code: L01BC05
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: GEMCITABINE
CAS Number: 95058-81-4
Concentration unit: mg/m2 milligram
Sponsors
Academisch Ziekenhuis Leiden acting under the name of Leids Universitair Medisch Centrum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically proven epithelial ovarian cancer, peritoneal cavity or fallopian tube cancer (inclusive mucinous or clear cell tumors) • Tumor expressing p53 • Progression of disease or relapse after previous therapy with platinum • Measurable disease (RECIST 1.1) or elevated CA125 > 2 times the upper limit of normal 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 upper limit of normal (UNL) range, ALAT and/or ASAT =2.5 x UNL, 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 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: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the feasibility to combine gemcitabine and Peg-intron with and without p53-SLP vaccination;Secondary Objective: • The effect of chemo-immunotherapy on the immune system by assessing changes in plasma signature, dendritic cell phenotype and T- and B-cell responses to known tumor antigens in ovarian cancer (eg p53) or antibodies to antigens associated with immunogenic cell death and in tumor tissue by gene array and PCR • The relation between anti-tumor immunity and clinical outcome (response (RECIST 1.1), progression free survival and overall survival) ;Primary end point(s): Feasibility of combining gemcitabine with interferon alpha and p53-vaccine in patients with recurrent ovarian cancer | — |
Countries
Netherlands
Outcome results
None listed