A research study to determine if the combination of trabectedin and PLD is better at improving overall survival over carboplatin and PLD in subjects with advanced ovarian cancer relapsed between 6 and 12 months from the end of a last platinum-based chemotherapy.
- Conditions
- Ovarian cancerMedDRA version: 16.1Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022949-17-NL
- Lead Sponsor
- Mario Negri Gynecologic Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 600
1. Female, aged = 18 years
2. Histologically and/or cytologically proven epithelial ovarian, epithelial fallopian tube cancer or primary peritoneal cancer
3. Progression free interval between six and twelve (6-12) months (calculated from the first day of the last cycle of the last platinumbased
chemotherapy until the date of progression confirmation through radiologic imagery). Patients may have received up to two platinum-based chemotherapy lines, of which at least one must have contained a taxane.
4. Measurable or evaluable disease confirmed by radiological imaging, such as magnetic resonance imaging (MRI), computed tomography (CT) scan, or PET/CT scan at study entry (CA-125 rise not supportedby radiological evidence of disease is not accepted as criteria for defining progression) or histological proven recurrent ovarian cancer even in the absence of postoperatively measurable or evaluable lesions.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2
6. Estimated life expectancy = 12 weeks
7. Patients must be accessible for treatment and follow-up.
8. Adequate organ function within 14 days prior to first cycle as evidenced by:
a. Peripheral blood counts and serum chemistry values:
i. Hemoglobin = 9 g/dl
ii. Absolute neutrophil count (ANC) = 1,500/µl
iii. Platelet count = 100,000/µl
iv. Estimated glomerular filtration rate > 60 ml/min according to the Cockroft-Gault formula
v. Creatine phosphokinase (CPK) = 2.5 x ULN
b. Hepatic function variables:
i. Total bilirubin = ULN
ii. Total alkaline phosphatase = 2.5 ULN (consider hepatic isoenzymes 5-nucleotidase if the elevation could be osseous in origin)
iii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be = 2.5 x ULN
9. Patients must be able to receive dexamethasone or its equivalent, which is required if randomly assigned to treatment with trabectedin plus PLD
10. Informed consent of the patient
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180
1. Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)
2. Patients who did not respond to last platinum-based therapy or in whom last relapse occurred < 6 months or > 12 months from the last dose of platinum
3. Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases
4. Pre-existing grade > 1 motor or sensory neuropathy according to the National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.0.
5. Myocardial infarct within six months before enrolment, New York Association (NYHA) Class II or worse heart failure (Appendix 1. The
New York Heart Association), uncontrolled angina, severe uncontrolled ventricular arrythmias, clinically significant pericardial
disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
6. History of liver disease.
7. Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
8. Breastfeeding women and women of child bearing potential must use effective contraception during treatment and 3 months thereafter, which may include prescription contraceptives (oral, injection, or patch), intrauterine device, double-barrier method or male partner sterilization (not applicable to patients that are surgically sterile)
9. Prior exposure to trabectedin
10. Prior resistance to anthracyclines or PLD defined as a progression during anthracycline based chemotherapy or a recurrence within 6 months from its ending
11. Prior severe PLD related toxicity
12. Prior exposure to cumulative doses of doxorubicin >400mg/m2 or epirubicin >720mg/m2
13. Treatment with any investigational product within 30 days prior to inclusion in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method