E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Epithelial Ovarian Cancer in Late Relapse (>6 months) |
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MedDRA Classification |
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 |
The primary objective of this trial is to compare progression-free survival (PFS) of patients in both study groups.(Carboplatin and Paclitaxel vs Caelyx and Carboplatin) |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this trial are to compare groups regarding: · Overall survival (OS) · Qualitative and quantitative toxicities · Quality of life
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
·Patients aged > 18 years ·Patients with a histological proven diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors ·Patients with measurable disease (RECIST criteria) or CA 125 assessable disease (GCIG criteria) or histological proven diagnosis of relapse ·Patients with disease in progression > 6 months after a first platinum-based line or a second platinum-based line. Patients should have received previously a taxane derivative ·Patients with ECOG performance status < 2 ·Patients with a life-expectancy of at least 12 weeks ·Adequate bone marrow, renal and hepatic function defined as - WBC > 3.0 x 109/l or Neutrophils (Absolute Neutrophil Count) ³ 1,5 ´ 109 /l - Platelets ³ 100 ´ 10 9/l - Hemoglobin > 6 mmol/l (> 10,0 mg/dl) - Bilirubin £ 2 ´ upper normal limit of normal range - Estimated glomerular filtration rate ³ 40 ml/min according to Cockroft-Gault formula ·Patients who have been through an informed consent discussion with the appropriate study-related health care representative, fully understanding the implications and constraints of the protocol and have given their written consent prior to the commencement of trial-related procedures. ·Patients must be geographically accessible for treatment and follow-up
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E.4 | Principal exclusion criteria |
·Ovarian tumors of low malignant potential (borderline tumors) ·Non-epithelial ovarian or mixed epithelial/non epithelial tumors (e.g. mixed Mullerian tumors) ·Patients who have received previous radiotherapy ·Patients with a prior diagnosis of malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) ·Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases ·Pre-existing motor or sensory neurologic pathology or symptoms NCI-CTCAE grade >1 ·History of congestive heart failure (NYHA Classification > 2, even if medically controlled). History of myocardial infarction within the last 6 months (documented clinically or by electrocardiogram). History of atrial or ventricular arrhythmias ·Patients with severe active infection ·Concurrent severe medical problems unrelated to malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy ·Patients with a history of severe hypersensitivity reactions to products containing Cremophor EL (cyclosporin or vitamin K) and/or patients with known hypersensitivity to compounds chemically related to Paclitaxel, Carboplatin, or Caelyx ·Fertile women not using adequate contraceptive methods ·Women who are pregnant or breast feeding ·Administration of other simultaneous chemotherapeutic drugs, or hormonal therapy, or simultaneous radiotherapy during the study treatment period (hormone replacement therapy is allowed as are steroidal antiemetics) ·Dementia or significantly altered mental status that would hinder the patient’s compliance and the understanding of the informed consent discussion.
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E.5 End points |
E.5.1 | Primary end point(s) |
(PROGRESSION-FREE SURVIVAL(PFS): The progression-free survival is calculated for all patients from the date of enrollment until the date of progressive disease, or death, whichever occurs first. Patients should not receive any therapy after completion of protocol treatment until progression is documented. OVERALL SURVIVAL (OS) Overall survival is calculated from the date of enrollment into the study until the date of death from any cause.
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | Yes |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 6 |