Randomized phase II study of 3 vs 6 courses of neoadjuvant carboplatin-paclitaxel chemotherapy in stage IIIC or IV epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma

• Conditions: neoadjuvant carboplatin-paclitaxel chemotherapy in stage IIIC or IV epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma; MedDRA version: 16.0Level: PTClassification code 10070908Term: Ovarian cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.0Level: PTClassification code 10070907Term: Ovarian cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.0Level: PTClassification code 10016187Term: Fallopian tube cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.0Level: PTClassification code 10068974Term: Peritoneal carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.0Level: PTClassification code 10016186Term: Fallopian tube cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002520-17-IT
• Lead Sponsor: AOU di Bologna, Policlinico S.Orsola-Malpighi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-07
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

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

Inclusion Criteria

Patients must fulfill all the following eligibility criteria in order to be eligible for this study:
a.Female patients =18 years.
b.Karnofsky Performance Scale = 60% (see Appendix I).
c.Histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with the exception of mucinous, clear cell and carcinosarcoma histologies.
d.Documented International Federation of Gynecologic Oncology (FIGO) stage IIIC-IV unsuitable for complete primary cytoreductive surgery. Inoperability must be confirmed by open laparoscopy or by laparotomy.
e.Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
•white blood cells (WBC) >3,000/µL, absolute neutrophil count (ANC) =1,500/µL, platelets (PLT) =100,000/µL, hemoglobin (Hb) =9 g/dL,
•serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance =60 mL/min according to Cockroft-Gault formula or to local lab measurement (Appendix III),
•serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.
f. Signed informed consent obtained prior to any study-specific procedures

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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

a.Mucinous, clear cell and carcinosarcoma histologies.
b.Synchronous or previous other malignancies within 3 years prior to starting study treatment, with the exception of adequately treated non-melanomatous skin cancer or carcinoma in situ (of the cervix or breast or other sites).
c.Patients with brain metastases, seizure not controlled with standard medical therapy, or history of cerebrovascular accident (CVA, stroke) or transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months from the enrollment on this study.
d.Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol (including but not limited to impaired cardiac function or clinically significant cardiac diseases, active or uncontrolled infections, HIV-positive patients on antiretroviral therapy, uncontrolled diabetes, cirrhosis, chronic active or

persistent hepatitis, impaired respiratory function requiring oxygen-dependence, serious psychiatric disorders).
e.Pregnant or breastfeeding women.

Study & Design

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