Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy Clinical Trial
Official title:
A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of ZD4054 (Zibotentan) Plus Carboplatin and Paclitaxel or Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
The purpose of this study is to compare progression-free survival in patients with advanced ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo in combination with carboplatin+paclitaxel.
| Status | Terminated |
| Enrollment | 120 |
| Est. completion date | June 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Histologically proven diagnosis of: - Epithelial ovarian carcinoma - Fallopian tube carcinoma - Primary serous peritoneal carcinoma - 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. - 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 Exclusion Criteria: - Clinical evidence of central nervous system (CNS) metastases - Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneum - Tumour of borderline malignancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Research Site | Berlin | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Dusseldorf | |
| Germany | Research Site | Essen | |
| Germany | Research Site | Karlsruhe | |
| Germany | Research Site | Kassel | |
| Germany | Research Site | Kiel | |
| Germany | Research Site | Lich | |
| Germany | Research Site | Magdeburg | |
| Germany | Research Site | Marburg | |
| Germany | Research Site | Munchen | |
| Germany | Research Site | Rostock | |
| Germany | Research Site | Wiesbaden | |
| Italy | Research Site | Aviano | PN |
| Italy | Research Site | Campobasso | |
| Italy | Research Site | Milano | MI |
| Italy | Research Site | Modena | |
| Italy | Research Site | Napoli | |
| Italy | Research Site | Perugia | PG |
| Italy | Research Site | Roma |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI |
Germany, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival | Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. | Patients were followed for progression up to 2 years | No |
| Secondary | Overall Survival | Median time (in months) from randomisation until death using the Kaplan-Meier method. | Patients were followed for survival up to 2 years | No |
| Secondary | Tumour Response Rate | Objective response rate defined as participants with a complete or partial response according to RECIST | While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years) | No |