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Sponsors and Collaborators: |
Medical Research Council NSGO ANZGOG AGO Ovarian Cancer Study Group Clinical Trials Awards and Advisory Committee AstraZeneca NCIC CTG GGroup d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens Grupo Espanol do Investigacion en Cancer do Ovario European Organization for Research and Treatment of Cancer |
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Information provided by: | Medical Research Council |
ClinicalTrials.gov Identifier: | NCT00532194 |
The purpose of this study is to assess the safety and efficacy of cediranib in combination with standard chemotherapy, in patients who have relapsed with ovarian, fallopian tube or epithelial cancer, after first line platinum based treatment.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: cediranib |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised Trial of Concurrent (With Platinum Based Chemotherapy) and Maintenance Cediranib in Women With Platinum Sensitive Relapsed Ovarian Cancer. |
Estimated Enrollment: | 2000 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2013 |
Arms | Assigned Interventions |
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Reference: Placebo Comparator
Patients in this arm will receive standard platinum based chemotherapy plus a daily oral placebo tablet for the duration of chemotherapy and then for up to 18 months from the time of randomisation or until protocol defined disease progression occurs.
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Drug: cediranib
once-daily oral tablet starting dose 30mg
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B: Active Comparator
Patients in this arm will receive standard platinum based chemotherapy plus a daily oral cediranib tablet during chemotherapy only and then an oral daily placebo tablet for up to 18 months from the time of randomisation or until protocol defined disease progression occurs.
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Drug: cediranib
once-daily oral tablet starting dose 30mg
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C: Active Comparator
Patients in this arm will receive standard platinum based chemotherapy plus a daily oral cediranib tablet during chemotherapy and continued for up to 18 months from the time of randomisation or until protocol defined disease progression occurs.
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Drug: cediranib
once-daily oral tablet starting dose 30mg
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The trial will be multi-arm and multi-stage. Patients will be randomised in a 2:3:3 ration to arms A, B and C. Patients in arm A (reference arm) will receive standard 6 X 3 week cycles of carboplatin and paclitaxel plus an oral placebo tablet they will take every day. At the end of chemo they will continue to take a placebo tablet every day for up to 18 months from randomisation. Patients in Arm B (concurrent arm) will get standard 6 cycles of chemo and take an oral daily cediranib tablet during chemo and then switch to take a daily placebo tablet for up to 18 months after randomisation.
Patients in arm C (concurrent and maintenance arm) will get standard chemo plus oral daily cediranib tablet during chemo and oral daily cediranib tablet for up to 18 months after randomisation. This will allow us to see if there is an added benefit of taking cediranib for a longer time after chemo has ended.
The trial will be conducted in 3 stages. The first stage will be done in 50 patients (33 in arms B and C) in 10 centres in Canada and the UK. After the patients have completed 3 cycles of chemotherapy an interim analysis will be conducted to assess the safety of cediranib in combination with carboplatin and paclitaxel used to treat this type of cancer. If the data monitoring committee are happy for the trial to continue as planned, further sites will be opened for stage 2. Stage 2 analysis will be conducted approximately 2 years after the stage 1 analysis when approximately 600 patients are anticipated to have been randomised. Stage 2 will assess whether a minimal level of efficacy is shown on progression free and overall survival, and this will indicate whether or not the trial will continue to stage 3. Stage 3 analysis will be conducted when approximately 2000 patients have completed at least 4 cycles of chemotherapy and will assess the efficacy of cediranib in terms of overall survival. The trial will also look at quality of life, toxicity and have health economics and translational research components.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Females aged >= 18 years with previous histologically proven diagnosis of
Adequate bone marrow function
Adequate liver function
Adequate renal function
Exclusion Criteria:
Evidence of severe or uncontrolled cardiac disease
Contact: Julie m Bakobaki, MSc | 020 7670 4896 ext 4896 | jmb@ctu.mrc.ac.uk |
Contact: Ann Marie Swart, PhD | 020 7670 4746 ext 4746 | ams@ctu.mrc.ac.uk |
Principal Investigator: | Jonathan Ledermann, Prof | University College, London |
Study ID Numbers: | 2007-001346-41, ISRCTN68510403 |
Study First Received: | September 19, 2007 |
Last Updated: | September 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00532194 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
ovarian cancer fallopian tube cancer primary serous peritoneal cancer gynaecological carcinoma |
randomised controlled trial Cediranib AZD2171 efficacy |
Fallopian Tube Cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Fallopian Tube Neoplasms Carcinoma Genital Diseases, Female Ovarian Cancer Endocrinopathy Endocrine Gland Neoplasms |
Genital Diseases, Female Neoplasms Neoplasms by Site Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Adnexal Diseases Endocrine Gland Neoplasms |