Patients with advanced ovarian cancer who have relapsed following first-line platinum containing therapy (Patients may have received any other chemotherapy agent with the platinum agent). Relapse must have occurred at least 6 months after cessation of first-line treatment. MedDRA version: 9.1 Level: LLT Classification code 10066697 Term: Ovarian cancer recurrent
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Females aged 18 years and older 3. Histologically proven diagnosis of: - Epithelial ovarian carcinoma - Fallopian tube carcinoma - Primary serous peritoneal carcinoma 4. Advanced disease not amenable to curative surgery or radiotherapy at the time of study entry with evidence of disease recurrence or progression at least 6 months following treatment cessation of first-line platinum-containing therapy and having stopped any maintenance therapy at least 30 days prior first dose of treatment with study drug (if applicable, excluding platinum-based maintenance therapy). 5. Radiologically documented measurable disease according to RECIST criteria assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) or radiologically documented non-measurable (but evaluable) disease. A non-measurable but evaluable patient is defined as a patient with a non-measurable soft tissue lesion (this includes bone lesions) that can be determined according to RECIST and documented via a CT or MRI scan. Patients with ascites and/or pleural/pericardial effusion only, are not considered as evaluable in this study 6. World Health Organisation (WHO) performance status 0 to 2 7. Estimated life expectancy of more than 16 weeks 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: Clinical evidence of central nervous system (CNS) metastases 2. Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneum 3. Tumour of borderline malignancy 4. A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) in the last 5 years 5. Inadequate bone marrow reserve as demonstrated either by an absolute neutrophil count <1.5 x 109/L or platelet count <100 x 109/L 6. Haemoglobin =9 g/dL (5.59 mMol/L) 7. Stage II, III or IV cardiac failure (classified according to New York Heart Association [NYHA] classification [see Appendix D]) or myocardial infarction within 6 months prior to study entry 8. Severe or frequent migrainous headaches
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare progression-free survival in patients with advanced ovarian cancer treated with ZD4054 in combination with carboplatin and paclitaxel versus ZD4054 matched placebo in combination with carboplatin and paclitaxel.;Secondary Objective: 1) To compare overall survival in patients with advanced ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo in combination with carboplatin+paclitaxel. 2. To compare the objective tumour response rate, as evaluated according to RECIST criteria in patients with advanced ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo in combination with carboplatin+paclitaxel. 3. To investigate the safety and tolerability of ZD4054 given in combination with carboplatin/paclitaxel in patients with advanced ovarian cancer. 4. To investigate the pharmacokinetics (PK) of ZD4054 in patients with advanced ovarian cancer as given in combination with carboplatin+paclitaxel. 5. To explore the effect of adding ZD4054 to a chemotherapy regimen of carboplatin+paclitaxel on patients’ health related quality of life (HRQoL).;Primary end point(s): The primary objective of this study is to compare progression-free survival in patients treated with ZD4054 on a background of carboplatin plus paclitaxel versus placebo on a background of carboplatin plus paclitaxel. | — |
Countries
Germany, Italy
Outcome results
None listed