se of doxorubicin liposomiale not peghilata (MYOCET) as second-line chemotherapy in epithelial ovarian carcinoma: Carboplatin + Myocet in patients Platinum sensitive or Myocet as single agent in patients Platinum resistant - DOXO

• Conditions: epithelial ovarian carcinoma recidivist; MedDRA version: 9.1Level: LLTClassification code 10061328

• Registration Number: EUCTR2010-023755-28-IT
• Lead Sponsor: IVERSITA` CAMPUS BIOMEDICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients suffering from recidivism of epithelial ovarian carcinoma, confirmed histologically, who had disease progression at least 6 months after the end of the first-line therapy with Platinum in single regime in combination.
2. all patients must have measurable disease or assessed. For measurable disease is defined as an injury that can be evaluated in clinical inspection or through diagnostic imaging ... For disease assessed means biopsy performed during surgery of second look, positive for neoplasia, despite ongoing intervention and through diagnostic imaging have not been observed occurrence of the disease, moreover with a CA125 negative. .
3. Patients with ECOG Performance status (Oken MM, 1982) = 2
4. patients were hospitalized recently for complications from surgery or chemotherapy. In particular, the patient should not have infectious events in progress. If the progression has occurred in the course of previous chemotherapy, waiting for recruitment in the Protocol must be at least 4 weeks.
5. previous Therapy:
-Patients must have made a previous chemotherapy regime containing Carboplatin, cisplatin or other drug made of Platinum.
-The patient must have previously signed up at least one chemotherapy regimen.
6. the patient shall have suitable values:
Marrow: WBC Features greater than or equal to 3,000/ul. Platelets are greater than or equal to 100, 000/ul. Granulocytes greater than or equal to 1,500/ul.
Kidney function: creatinine less than or equal to 1.5 mg/dl: hepatic Bilirubin, SGOT and SGPT less than or equal to 1.5 times the norm. Alkaline phosphatase less than or equal to 2.5 the norm.
Ventricular ejection fraction (LVEF) 50% in echocardiography.
7. Patients who signed informed consent.
8. patients who respond to parametric described in section 7.0.
9. having Patients over the age of 18 years.
10. patients with negative pregnancy test.
11. patients with a life expectancy of more than 12 months
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Platinum-resistant Patients, or patients who have recidivato within 6 months of the deadline by terpia platinum based on even during therapy.
1b. Platinum-sensitive Patients.
2. patients who have tumors gynecological not concurrent.
3. Patients suffering from cancer of Brenner or borderline ovarian cancer.
4. Patients who have not previously received any type of chemotherapy ...
5. Patients who have previously received a cumulative dose of Doxorubicin > 350 mg/m2 and/or Epirubicin > 540 mg/m2.
6. patients who have history of allergy to anthracycline and/or eggs ...
7. Patients suffering from cardiovascular disease.
8. Patients with Hemoglobin < 9 g/dl; WBCs < 1500/l; Platelets < 100,000//l; Creatinine > 1.5 mg/dl; SGOT, SGPT > 1.5 5times higher than normal.
9. Patients affettti from serious illnesses for which the administration of chemotherapy would expose the patient at risk too high.
10. patients who refused to sign the consent form.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified