E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
EPITHELIAL OVARIAN CANCER FALLOPIAN TUBE CARCINOMA PRIMARY PERITONEAL CARCINOMA |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033128 |
E.1.2 | Term | Ovarian cancer |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052204 |
E.1.2 | Term | Ovarian carcinosarcoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016180 |
E.1.2 | Term | Fallopian tube cancer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• To assess the safety profile of bevacizumab when added to carboplatin and paclitaxel chemotherapy as front-line treatment of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. |
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E.2.2 | Secondary objectives of the trial |
•To assess the efficacy of bevacizumab as measured by: - progression-free survival - overall response rate: - by RECIST and 50% CA-125 response criteria (“responders”) - by RECIST only (“RECIST responders”) - by 50% CA-125 response criteria only (“CA-125 responders”) - duration of response - overall survival - biological progression-free interval
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Collection of optional biomarker samples for Roche Clinical Repository (RCR) to assess non-inherted, genetic and tissue biomarkers:
Specimens taken for biomarker research will be used to: • study early, intermediate and late escape mechanisms related to bevacizumab and chemotherapy regimen • increase our knowledge and understanding of disease biology • study the association of biomarkers with response and adverse reactions • develop biomarker or diagnostic assays and to establish the performance characteristics of these assays
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E.3 | Principal inclusion criteria |
• Histologically confirmed and documented high risk International Federation of Gynecologic Oncology (FIGO) Stage I–IIa (only if grade 3 / poorly differentiated) or Stage IIb–IV (any grade) epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or Or Histologically confirmed and documented clear cell carcinoma regardless of the FIGO stage (clear cell carcinoma is defined as either ≥ 50% clear cell elements present or reported as clear cell carcinoma by the local pathologist). Or Histologically confirmed and documented carcinosarcoma. Patients with recurrent ovarian cancer that have been previously treated with surgery alone for their early stage disease are eligible.
• Patients should have already undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction according to the GCIG Conference Consensus Statement. There must be no planned surgical debulking prior to disease progression. Patients with stage III and IV disease in whom initial surgical debulking was not appropriate will still be eligible providing - the patient has a histological diagnosis and - debulking surgery prior to disease progression is not foreseen
• Eligible for carboplatin (or cisplatin) and paclitaxel chemotherapy treatment in accordance with local standards of care following cytoreductive surgery. Patients who have received neo-adjuvant chemotherapy may be included. In such patients bevacizumab is started in addition to the post-surgical chemotherapy cycles.
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E.4 | Principal exclusion criteria |
Patients with: • non-epithelial ovarian cancer • ovarian tumors with low malignant potential (i.e. borderline tumors) • synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met: o stage ≤Ia o no more than superficial myometrial invasion o no lymphovascular invasion o not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma). • Previous systemic therapy for ovarian cancer (i.e. chemo-, immuno-, hormonal, monoclonal antibody or tyrosine kinase inhibitor therapy). Prior neo-adjuvant chemotherapy is allowed. • Radiotherapy within 28 days of Day 1, Cycle 1. Patients may be given palliative radiotherapy to peripheral sites (e.g. bone metastasis) during this 28 day period but they must have recovered from any acute effects. Prior radiotherapy to any portion of the abdominal cavity or pelvis is not permitted. • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of bevacizumab. or anticipation of the need for major surgery during the course of the study treatment (planned elective surgery).
• Inadequate bone marrow function / liver function / renal function
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E.5 End points |
E.5.1 | Primary end point(s) |
safety endpoint: - The primary variable is the incidence rate of adverse events and rates for selected events with incidences less than 1% - The rate of adverse events is defined as the proportion of patients from the safety population that experienced at least one, or a specific AE.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 137 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of study is defined as the date the last patient completes the 36th cycle of bevacizumab treatment. Patients will be followed (for survival and for progression-free survival) until 30 days after the last treatment cycle with bevacizumab in any patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |