Combined Intraperitoneal Chemotherapy Regimen After Optimal Interval Surgery in Advanced Ovarian Cancer: BICOV-1 (Bidirectional Chemotherapy in Ovarian Cancer)

NCT06902467 | Recruiting

• 1 other identifier: IMIB-BICOV-2022-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, low-intervention, drug-based study to evaluate the feasibility and safety of a combined regimen of two intraperitoneal chemotherapy modalities (used in routine clinical practice) following interval surgery for the treatment of advanced ovarian cancer. This is an independent research project (free of commercial interests).

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free interval

  Number of days without disease

  Up to 5 years

Secondary Outcomes (2)

• Safety related to the intervention

  Up to 5 years

• Quality of life of the participants

  Up to 5 years

Study Arms (1)

Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, pat

EXPERIMENTAL

Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, patients in the study will receive 4 cycles of 21 days every 3 weeks of the regimen studied by Armstrong 8 and modified by GEICO 18: IV paclitaxel 175 mg /m2 (day 1) + IP cisplatin 100 mg/m2 (day 2) + IP paclitaxel 60 mg/m2 (day 8).

Drug: Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, patients in the study will receive 4 cycles of 21 days every 3 weeks of the regimen studied by Armstron

Interventions

Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, patients in the study will receive 4 cycles of 21 days every 3 weeks of the regimen studied by Armstron DRUG

Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, patients in the study will receive 4 cycles of 21 days every 3 weeks of the regimen studied by Armstrong 8 and modified by GEICO 18: IV paclitaxel 175 mg /m2 (day 1) + IP cisplatin 100 mg/m2 (day 2) + IP paclitaxel 60 mg/m2 (day 8).

Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, pat

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Twenty patients aged between 18 and 75 years, diagnosed with FIGO stage IIIB-IV epithelial ovarian cancer (high-grade serous epithelial carcinoma) and previously treated with systemic neoadjuvant chemotherapy, followed by cytoreduction + HIPEC and postoperative combined systemic and intraperitoneal chemotherapy, will be initially selected.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18-70 years with a histologically proven diagnosis of FIGO stage IIIB-C/IV epithelial ovarian cancer (high-grade serous epithelial carcinoma)
• Absence of extraperitoneal disease.
• Good performance status: Karnofsky score \>70 or Performance status \<= 2
• Adequate liver function, defined as bilirubin \<0.15 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase \<= 2.5 times ULN, and alkaline phosphatase \<= 3 times ULN.
• Adequate 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 serum and urine pregnancy test results for women of childbearing potential at the screening visit.
• Administration of neoadjuvant chemotherapy with a total of 3 or 4 systemic cycles.
• Surgery with complete CC0 cytoreduction without digestive anastomoses.
• Patients who have signed the written IC.

You may not qualify if:

• Disease progression during systemic treatment with neoadjuvant chemotherapy.
• Extraperitoneal disease (including retroperitoneal lymph node metastases)
• Inability to achieve complete cytoreduction (CC-0) during preoperative (imaging) or intraoperative evaluation.
• Performance of at least one digestive anastomosis of any type. 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 within the last 30 days.
• Pregnant or breastfeeding women, where pregnancy is defined as the state of a woman after conception and until the end of pregnancy, confirmed by a positive human chorionic gonadotropin (hCG) test result, or who plan to become pregnant or breastfeed during study treatment or within 30 days of the end of treatment with the study drug.
• Patients with a history of allergic reactions or hypersensitivity to drugs chemically related to cisplatin and paclitaxel.
• Failure to sign written informed consent.

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

HCUVA

Murcia, 30120, Spain

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Pedro Cascales Campos, MD

  HCUVA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Cascales Campos, MD

CONTACT

968369500; cascalescirugia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, patients in the study will receive 4 cycles of 21 days every 3 weeks of the regimen studied by Armstrong 8 and modified by GEICO 18: IV paclitaxel 175 mg /m2 (day 1) + IP cisplatin 100 mg/m2 (day 2) + IP paclitaxel 60 mg/m2 (day 8).

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: February 27, 2023
• Primary Completion: March 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

ES (1)