Clinical trial NCT00929162: ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
Keywords: ovarian
cancer
chemotherapy
sensitive
ZD4054
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI
First posted: 2009-06-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: Patients were followed for progression up to 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Patients were followed for survival up to 2 years
measure: Tumour Response Rate
timeFrame: While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Dusseldorf
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Karlsruhe
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Lich
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Milano
country: Italy
facility: Research Site
state: MI
city: Perugia
country: Italy
facility: Research Site
state: PG
city: Aviano
country: Italy
facility: Research Site
state: PN
city: Campobasso
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
Study officials:
affiliation: AstraZeneca, Alderley Park
name: Tom Morris
role: STUDY_DIRECTOR
affiliation: AstraZeneca, Alderley Park
name: Ian Thomas
role: STUDY_CHAIR
References:
citation: Cognetti F, Bagnato A, Colombo N, Savarese A, Scambia G, Sehouli J, Wimberger P, Sorio R, Harter P, Mari E, McIntosh S, Nathan F, Pemberton K, Baumann K. A Phase II, randomized, double-blind study of zibotentan (ZD4054) in combination with carboplatin/paclitaxel versus placebo in combination with carboplatin/paclitaxel in patients with advanced ovarian cancer sensitive to platinum-based chemotherapy (AGO-OVAR 2.14). Gynecol Oncol. 2013 Jul;130(1):31-7. doi: 10.1016/j.ygyno.2012.12.004. Epub 2012 Dec 9.