epithelial ovarian cancer in late relapse
Conditions
Interventions
Trade Name: Caelyx-Carboplatin
Product Name: Caelyx-Carboplatin
Pharmaceutical Form:
Sponsors
ARCAGY (Association de Recherche sur les Cancers Gynécologiques)
Eligibility
Sex/Gender
All
Inclusion criteria
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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 850 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to compare progression-free survival (PFS) of patients in both study groups.;Secondary Objective: The secondary objectives of this trial are to compare groups regarding: · Overall survival (OS) · Qualitative and quantitative toxicities · Quality of life;Primary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Countries
Austria, Belgium, Denmark, Finland, Germany, Italy, Netherlands, Portugal, Saudi Arabia, Spain, Sweden, Turkey, United Kingdom
Contacts
Public ContactPr Eric PUJADE-LAURAINE, MD, PhD.
Association de Recherche sur les Cancers Gynécologiques
Outcome results
None listed