A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of ZD4054 plus Carboplatin and Paclitaxel or Placebo plus Carboplatin and Paclitaxel in Patients with Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
- Conditions
- 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: 9.1Level: LLTClassification code 10066697Term: Ovarian cancer recurrent
- Registration Number
- EUCTR2008-006068-12-DE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 122
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
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
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