Ovarian cancer resistant to the treatment with platinum MedDRA version: 18.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Yondelis 0,25 mg
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: TRABECTEDIN
CAS Number: 114899-77-3
Current Sponsor code: TRABECTEDIN
Other descriptive name: TRABECTEDIN
C
Sponsors
Fundación para la investigación biomédica del Hospital Clínico San Carlos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological or cytological diagnosis of epithelial carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma. 2. Pretreatment with carboplatin + paclitaxel, carboplatin or gemcitabine + carboplatin + liposomal doxorubicin. 3. Resistance to treatment with platinum. 4. Two or three lines of previous chemotherapy. 6. ECOG PS 0-1 7. Adequate bone marrow function: 8. Creatinine clearance ? 30 ml / min, serum creatinine ? 1.5 mg / dL (? 132.6 mmol / l). Creatine phosphokinase (CPK) ? 2.5 x ULN 10. Adequate hepatic function. 11. Negative pregnancy test within 7 days prior to initiation of treatment. 12. Women age: for the use of effective contraception during treatment and for 3 months thereafter. 13. Informed consent of the patient. 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 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have received more than three prior chemotherapy lines. 2. Prior exposure to trabectedin or hypersensitivity to any of the excipients 3. Any severe or uncontrolled as, for example, uncontrolled systemic infection requiring therapy condition. 4. Other prior malignancy treated within 5 years prior to enrollment in the study, except nonmelanoma skin carcinoma completely resected or in situ of the cervix or the cervix or basal cell skin carcinoma treated with curative intent . 5. Any uncontrolled serious pre-existing medical or psychiatric condition and / or that could interfere with subject's safety, provision of informed consent or comply with study procedures. 6. Metastatic brain or leptomeningeal disease. 7. Treatment with any investigational product within 30 days prior to study entry. 8. Pregnant or lactatiom 9. significant chronic liver disease such as cirrhosis or active hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective response rate and time to pathology progression (assessed according to RECIST 1.1);Secondary Objective: Time to progression of the 4th / 5th line treatment (platinum regimen subsequent to treatment with trabectedin) compared to the time to progression of the 2nd / 3rd line (regime prior to inclusion in the study platinum) (TTP Pt2 / TTP Pt1). To be considered positive, the result must be ?1. Time to progression with the treatment of trabectedin versus Pt2 TTP / TTP ratio Pt1 Time to progression with the treatment of trabectedin versus TTP Pt.2 Duration of response to treatment with trabectedin. To assess whether progression-free survival with trabectedin added to the progression-free survival of subsequent platinum makes the platinum-free interval greater than 6 months Serological response of CA-125 according to the criteria of GCIG Assessing the quality of life of patients during treatment with trabectedin by QLQ-C30 questionnaire and the specific module QLQ-OV28 ovarian cancer. To assess the safety profile of trabectedin;Primary end point(s): Radiological assessment of patient response;Timepoint(s) of evaluation of this end point: at 9 and 18 weeks of initiation of therapy and then every 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical benefit rate according to modified RECIST criteria (version 1.1) to treatment with trabectidina. Time to progression since the introduction and trabectedin to progression from the start of the subsequent processing based on carboplatin (TTP Pt2) to progression. Growth Modulation Index Quality of Life Safety profile of drugs;Timepoint(s) of evaluation of this end point: in all the visits | — |
Countries
Spain
Contacts
Public Contactana belen rivas paterna
UICEC
Outcome results
None listed