This is a Phase II trial to determine the efficacy of intravenous CNTO 328 in women with the following diseases: recurrent epithelial ovarian cancer, Fallopian tube carcinoma, primary peritoneal carcinoma of serous, endometrioid or clear cell sub-types. MedDRA version: 9.1 Level: LLT Classification code 10066697 Term: Ovarian cancer recurrent
Conditions
Interventions
Product Name: CNTO328
Product Code: CNTO328
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Not available
Current Sponsor
Sponsors
Queen Mary, University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Women with recurrent histologically confirmed ovarian carcinoma, Fallopian tube carcinoma, or primary peritoneal carcinoma of serous, endometrioid or clear cell sub-types. • Previous treatment with no more than three platinum-containing chemotherapy regimes. • Patients are also eligible if they have relapsed within six months of completing first line platinum-containing chemotherapy or have experienced documented progression whilst receiving first-line platinum-containing chemotherapy • Life expectancy of at least 3 months • Age = 18 years • WHO performance status of 0, 1 or 2 • Patients must have the following clinical laboratory values: Granulocyte count > 1.0 x 109/l Platelet count > 100 x 109/l Hb > 9.0 g/dl Serum creatinine 30 g/dl Prothrombin and activated partial thromboplastin times =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Tumours of malignant mixed mesodermal (MMMT) or mucinous types. • Unresolved bowel obstruction • Prior administration of or hypersensitivity to humanised monoclonal antibodies • Chemotherapy within the preceding 3 weeks • Radiotherapy within the preceding 3 weeks • Treatment with any investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer. Known leptomeningeal involvement • Pregnant or lactating females. • Inability or unwillingness to give informed consent. • Ongoing active infection or a documented history of HIV infection, Hepatitis B or C. • Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease (Appendix 7). • Concurrent autoimmune disorder, e.g. systemic lupus or any demyelinating disease. • No corticosteroids to be taken within the preceding 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine efficacy of intravenous CNTO 328 in women with recurrent epithelial ovarian cancer.; Secondary Objective: a) To determine changes in Quality of Life in patients with recurrent epithelial ovarian cancer following treatment with CNTO328. b) To determine the neutralisation of IL-6 in tumour, blood and ascitic specimens following treatment with CNTO328. c) To determine the alterations in inflammatory markers in blood, ascitic fluid and tumour tissue (where possible) following intravenous delivery of CNTO 328 in recurrent epithelial ovarian cancer and determine whether any of these biomarkers are predictive of response. ;Primary end point(s): The primary endpoint will be any response (SD, PR or CR) in any of the patients. All patients will be staged with conventional (CT) imaging prior to treatment, after 5 treatments and every 3 months until end of treatment, to assess disease response to CNTO 328. Measurable disease in the CT component will be assessed by modified RECIST criteria.. CA-125 will also be measured at enrolment, prior to each infusion and at the end treatment. CA-125 responses will also be assessed according to the criteria of the GCIG and correlated to the CT response. Patients will additionally be investigated with [18F]-FDG PET scan imaging. The FDG-PET responses will be assessed according to the criteria of Avril et al. | — |
Countries
United Kingdom
Outcome results
None listed