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

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 sitesSeptember 7, 2007

Overview

No summary available.

Registry

who.int

Start Date

September 7, 2007

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

•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

•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