Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer
Conditions
Keywords
ovarian cancer
Brief summary
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.
Detailed description
Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.
Interventions
DRUGVinorelbine and Gemcitabine
Gmcitabine 1000㎎/㎡ mix in normal saline 100ml iv for 30min andVinorelbine 25㎎/㎡ mix in normal saline 50 ml iv for 5-10min on D1 and 8 every 21 days cycle
Sponsors
The Catholic University of Korea
Korean Cancer Study Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (complete response and partial response) | 16 weeks | radiologically assessed response every two cycles, according to RECIST ver 1.1 criteria and serologically assessed CA 125 response every two cycles, according to Rustin's criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 6months | fom the date of enrollment until the date of confimed progressive disease or death |
| overall survival | 1year | from the date of enrollment to death any cause |
| Frequency and severity of adverse effects | every cycle , from enrollment until death | assesed by the NCI-CTCAE ver 3.0 |
Countries
South Korea
Outcome results
None listed