Combined treatment of intraperitoneal chemotherapy after optimal interval surgery in advanced ovarian cancer. BICOV-1 (Bidirectional Chemotherapy in Ovarian Cancer).

Phase 1

Conditions: Ovarian cancer
MedDRA version: 20.0Level: PTClassification code: 10033128Term: Ovarian cancer Class: 100000004864
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Registration Number: CTIS2022-502691-23-00

Lead Sponsor: Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Women between 18-70 years of age with a proven histological diagnosis of FIGO stage IIIB-C/IV epithelial ovarian cancer (high-grade serous epithelial carcinoma)., CC0 complete cytoreduction without digestive anastomosis., Patients who have signed the written informed consent (IC)., Absence of extraperitoneal disease., Adequate functional status: Karnofsky index >70 or Performance status = 2, Correct liver function, defined as bilirubin <0 1.5 times the upper limit of normal (ULN), aspartate amino transferase and alanine amino transferase = 2.5 times ULN, and alkaline phosphate = 3 times ULN, Correct renal function, defined as serum creatinine = 1.5 times ULN, Acceptable bone marrow function defined as neutrophils >1.5 x 106 l-1, hemoglobin > 10 g/dl-1 and platelets >100.0 x 109 l-1, Absence of cardiac, pulmonary, hepatic, renal, or neurological disease that contraindicates major surgery., Negative result in serum and urine pregnancy test for women of childbearing age at screening visit., Administration of neoadjuvant chemotherapy with a total of 3 systemic cycles.

Exclusion Criteria

Disease progression after initiation of systemic neoadjuvant chemotherapy., Extraperitoneal disease (including retroperitoneal nodal metastases) at reassessment after systemic neoadjuvant therapy., Impossibility of achieving complete cytoreduction (CC-0)., Active infection of any origin., Allogeneic transplant, or prior bone marrow transplant, or high-dose chemotherapy with bone marrow or stem cell rescue., Participation in a clinical trial with an investigational drug in the last 30 days., Pregnant or lactating women, where pregnancy is defined as the state of a woman after conception and until the end of gestation, confirmed by a positive human chorionic gonadotropin (hCG) test result, or who plans to become pregnant o plan to breast-feed during study treatment or within 30 days of cessation of study drug treatment., Patients with a history of allergic reactions or hypersensitivity to drugs chemically related to cisplatin and paclitaxel., Failure to sign the written informed consent.