Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

A Phase II Study of Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Epithelial Ovarian/Fallopian Tube/ Primary Peritoneal Carcinoma.

The purpose of this study is to evaluate the objective response rate and safety in platinum-resistant epithelial ovarian/fallopian tube/primary peritoneal cancer patients treated with vinorelbine and gemcitabine combination chemotherapy.

Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.

Inclusion Criteria:

• Participants must sign an approved informed consent form (ICF)
• Histologically or cytologically confirmed epithelial ovarian/fallopian tube/primary peritoneal carcinoma
• Patients had to have received a front-line, platinum/taxane based chemotherapy regimen
• Patients who progressed or whose best response to their most recent platinum-based therapy was less than a partial response will be classified as having platinum-refractory/resistant ovarian cancer or progressed within six months of completing the most recent platinum-based chemotherapy
• Participants must have received prior platinum-based chemotherapy for management of primary disease but must not have received more than 3 prior systemic cytotoxic regimens.
• Patients had to have at least one bidimensionally measurable and/or evaluable (unidimensionally measurable) target lesion in a non-irradiated area and increased Ca 125
• A >= 4 weeks interval between their last chemotherapy regimen and the start of study treatment
• Age 20-75 years old
• Performance status (WHO) 0-2
• Life expectancy of at least three months
• Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
• Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2 mg/dl)

Exclusion Criteria:

• prior therapy with vinorelbine or gemcitabine
• treatment with > 2 cytotoxic regimens (including primary platinum and taxane chemotherapy)
• Serious comorbidities (as determined by the investigator) such as, but not limited to, active congestive heart failure, recent myocardial infarction or active infection.
• Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
• Symptomatic central nervous system (CNS) metastasis.
• Uncontrolled intestinal obstruction
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational
• Pregnant or nursing.