Reintroduction of platinum-based therapy after treatment with trabectedin in patients with relapsed ovarian cancer resistant to platinum

Phase 1

Active, not recruiting

Conditions: Ovarian cancer resistant to the treatment with platinum
MedDRA version: 18.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-004020-21-ES

Lead Sponsor: Fundación para la investigación biomédica del Hospital Clínico San Carlos

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: Female

Target Recruitment: 12

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

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