E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
epithelial ovarian cancer in late relapse |
|
E.1.1.1 | Medical condition in easily understood language |
ovarian cancer in late relapse |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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. |
|
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 |
|
E.2.3 | Trial contains a sub-study | No |
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 with histological proven diagnosis of relapse - Patients with disease in progression > 6 months after a first or second platinum-based line. Patients should have previously received 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 (*ANC) ³ 1,5 ´ 109 /l *Absolute Neutrophil Count · 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.
|
|
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 informed consent discussion. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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 | No |
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 | 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 | 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 | 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 | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 120 |
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 | No |
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 |
|
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
|
|
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 |