Oncoxin-Viusid-Advanced or metastatic ovarian epithelial cancer-Adult women-Phase II

Phase 2

Conditions: Epithelial advanced or metastatic ovarian cancer
Carcinoma
Ovarian Neoplasms
Endocrine Gland Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female

Registration Number: RPCEC00000269

Lead Sponsor: Catalysis Laboratory S.L.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 40

Inclusion Criteria

1. Female patients 18 years of age or older.
2. Patients with diagnosis of ovarian epithelial cancer in stages III (not resectable) and IV.
3. Patients with general health status according to the Karnofsky Index = 70 (Annex 12)
4. Life expectancy equal to or greater than 3 months.
5. Patients who give their informed consent in writing to participate in the study.
6. Normal functioning of organs and bone marrow defined by the following parameters:
-Hemoglobin = 90 g / L
- Total Leukocyte count = 3.0 x 109 / L
Absolute Neutrophil Count = 1.5 x 109 / L
-Platelet count = 100 x 109 / L
-Glycemia values = 10 Umol / L
-Values of Creatinine and total bilirubin within the normal limits of the institution.
-Values of AST / ALT =2.5 times the upper limit of the normal interval established in the institution.
7. Patients with a history of cardiovascular disease, with ejection fraction = 55%, measured by echocardiogram.

Exclusion Criteria

1. Patients who are receiving another research product.
2. Patients with known hypersensitivity to QT with Carboplatin, Cisplatin and / or Paclitaxel.
3. Patients in stage III tributary of surgical treatment at diagnosis.
4. Patients with known hypersensitivity to any ingredient of the product research.
5. Decompensated intercurrent diseases, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver diseases and psychiatric illnesses that could limit adherence to the requirements of the clinical trial or any other special condition that at the discretion of the physician put your health or life at risk during your participation in the trial.
6. Pregnancy, breastfeeding or puerperium.
7. Patients with brain metastases and/or leptomeningeal carcinosis.
8. Patients’ carrier of the human immunodeficiency virus (HIV)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life. It will measured by:<br>- EORTC QLQ-C30 (Points of every item and final points). Measurement time: at baseline and, 3 weeks after finished the third CT cycle<br>- EORTC QLQ-OV28 (Points of every item and final points). Measurement time: at baseline and, 3 weeks after finished the third CT cycle<br>- Karnofsky index (Score of 0-100 points at intervals of 10). Measurement time: at baseline, in every CT cycle and, 3 weeks after the third CT cycle

Secondary Outcome Measures