A Phase II Study of Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Epithelial Ovarian/Fallopian Tube/ Primary Peritoneal Carcinoma.
- Participants must sign an approved informed consent form (ICF)
- Histologically or cytologically confirmed epithelial ovarian/fallopian tube/primary
- Patients had to have received a front-line, platinum/taxane based chemotherapy
- 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
- Patients had to have at least one bidimensionally measurable and/or evaluable
(unidimensionally measurable) target lesion in a non-irradiated area and increased Ca
- A >= 4 weeks interval between their last chemotherapy regimen and the start of study
- 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)
- prior therapy with vinorelbine or gemcitabine
- treatment with > 2 cytotoxic regimens (including primary platinum and taxane
- Serious comorbidities (as determined by the investigator) such as, but not limited
to, active congestive heart failure, recent myocardial infarction or active
- 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.