A Phase II Study of Intravenous CNTO328 in Patients with Recurrent Epithelial Ovarian Cancer - CNTO328 in ovarian cancer
- Conditions
- 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
- Registration Number
- EUCTR2006-005704-13-GB
- Lead Sponsor
- Queen Mary, University of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
•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 < 1.5 x Upper Limit of Normal (ULN)
Bilirubin < 30 µmol/l
Albumin > 30 g/dl
Prothrombin and activated partial thromboplastin times < 1.5 x ULN
Alk Phos < 5 x ULN
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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method