Two Therapeutic Strategies in First-line in Patients With Epithelial Advanced Ovarian Cancer (CHIMOVIP)

Groupe Hospitalier Diaconesses Croix Saint-Simon

Status and phase: Enrolling; Phase 2

Conditions: Ovarian Cancer, Epithelial

Treatments: Drug: CC>0 - Cisplatin (IP/IV)- Epirubicin (IV); Drug: CC0 - Cisplatin (IP) - Epirubicin (IV); Drug: CC>0 - Carboplatin (IV)- Paclitaxel (IV); Drug: CC0 - Carboplatin (IV) - Paclitaxel (IV)

Study type: Interventional

Funder types: Other

Identifiers

NCT03025477

RVT_2015_2

Details and patient eligibility

About

CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.

Full description

This is a randomized phase II study, open-label and multicentric. After initial intervention (debulking surgery or diagnostic surgery) patient will randomized in the study according to Completeness of cytoreduction (CC) score (CC0 or CC>1).

Enrollment: 84 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed advanced (FIGO stage III or IV) invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian-tube cancer. Pleural cytology has to be performed in patients with pleural effusion.
• Initial intervention : debulking surgery or diagnostic surgery in the 3 weeks before inclusion
• Age ≥18 and < 75 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 before surgery (ECOG ≤ 1 and Lee score < 6 in patients > 70 years old).
• Adequate blood count (test realized in the past 14 days before inclusion) : neutrophils > 1500/mm3, platelets > 150 000/mm3.
• Creatinine clearance MDRD ≥ 60 mL/min
• Registration in a national health care system (CMU included).
• Signed and dated informed consent.

Exclusion criteria

• FIGO stage IV extra-abdominal disease, with the exception of lymph nodes and pleural invasion.
• Patient having received previous chemotherapy for ovarian cancer.
• Left ventricular ejection fraction < 50% before chemotherapy initiation
• Other invasive cancer in the past 5 years (baso- and spinocellular cutaneous carcinoma with complete resection are accepted)
• Concomitant administration of prophylactic phenytoin or live attenuated viral vaccines such as yellow fever vaccine,
• Patients with known hypersensitivity to any component of study drug
• Patients without motivation or capacity to respect study requirements and constraints
• Pregnancy or breast feeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Control arm

Active Comparator group

Description:

Initial or interval surgery associated with 6 cycles of chemotherapy in intravenous (IV) of carboplatin and paclitaxel. The regimen of administration of the chemotherapy is as following: * Carboplatin AUC 6 - IV - Day (D) 1 * Paclitaxel 80mg / m² - IV - D1, D8, D15 one cycle every 3 weeks

Treatment:

Drug: CC0 - Carboplatin (IV) - Paclitaxel (IV)

Drug: CC>0 - Carboplatin (IV)- Paclitaxel (IV)

Experimental arm

Experimental group

Description:

Initial or interval surgery associated with 6 cycles of chemotherapy of cisplatin and epirubicin. * Cisplatin is administrated in intraperitoneal (IP) if no macroscopic residual tumor at the end of the intervention (initial or interval). If evidence of macroscopic residual tumor, cisplatin is administered in IV. Epirubicin is always given in IV. * Second cytoreduction surgery at mid-term of chemotherapy cycles, only in patients operable in response after 3 cycles and with persistent residual disease after initial surgery or incomplete initial staging. The regimen of administration of the chemotherapy is as following: * Cisplatin 80mg / m² - IV or IP - D1 * Epirubicin 60mg / m² - IV - D3 one Cycle every 3 weeks.

Treatment:

Drug: CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)

Drug: CC0 - Cisplatin (IP) - Epirubicin (IV)