A phase II trial of carboplatin and paclitaxel compared with carboplatin or gemcitabine paclitaxel induction followed by carboplatin/paclitaxel/gemcitabine in patients with suboptimally resected stage III or IV ovarian carcinoma - ND

• Conditions: Epithelial ovarian carcinoma; MedDRA version: 6.1Level: PTClassification code 10033163

• Registration Number: EUCTR2006-000126-31-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-07
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Histologically proven ovarian carcinoma with evidence of residual tumour >= 1 cm after first surgery (carcinosis are included), advanced epithelial ovarian carcinoma, stages III and IV (documented by cytology or histology)

presence of at least one indicator lesion to be used for assessment of response; the best indicator for response evaluation is surgery laparoscopy or laparotomy. other indicator lesions must meet criteria for measurable or evaluable disease and must be defined by radiological study (including CT or MRI scan) ultrasound, or chest x-ray) or physical exam.

no previous chemo or radiotherapy

females >18 anni

performance status of 0 to 2 on ECOG scale

Estimated life expectancy of at least 12 weeks.

Adequate marrow function defined as WBC >=3 x 109, granulocytes >=1,5 x 109/L and platelets >=100 x 109/L, hemoglobin >=10 g/dl

Adequate hepatic function defined as total bilirubin <= 1,5 x ULN, ALT/AST =< 1,5 x ULN

Adequate renal function defined as creatinine =<1,3 mg/dl

Written informed consent

Start of chemotherapy within 6 weeks since surgery
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Epithelial ovarian carcinoma with residual tumour < 1cm after primary surgery.

prior anticancer treatments with chemotherapy, immunotherapy or radiotherapy

History or presence of malignancies, except for cured non-melanoma skin cancer, or carcinoma in situ of the uterine cervix.

Current peripheral neuropathy NCI grade >= 2.

Concurrent treatment with other experimental drugs

Significant neurological or psychiatric disorders that would prohibit patients to understanding or rendering informed consent or from fully complying with treatment and follow up.

Hepatic functions abnormalities: AST and/or ALT >= 1,5 x UNL associated with alkaline phosphatase > 2,5 x UNL

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the response rate between the three arm;Secondary Objective: To evaluate the progression free survival and survival rate at 3 years from first diagnosis of three following treatment regimens: paclitaxel combined with carboplatin on day 1 (arm A) versus carboplatin induction in high doses for two courses (arm B) or gemcitabine in high doses + paclitaxel weekly induction one course followed by paclitaxel, carboplatin (day 1) and gemcitabine (day 18) (arm C).<br><br>to evaluate the time to progression of the three regimens.<br><br>to determine the quantitative and qualitative toxicities of the two induction combination regimens (arm B and arm C).;Primary end point(s): Appraisal of objective answer between the three arms