Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer
- Conditions
- Ovarian CancerPrimary Peritoneal CancerFallopian Tube Cancer
- Interventions
- Registration Number
- NCT01196559
- Lead Sponsor
- The Catholic University of Korea
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 44
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vinorelbine and Gemcitabine Vinorelbine and Gemcitabine Vinorelbine 25 ㎎/㎡ and Gemcibine1000㎎/㎡ D1, D8 every 3weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Frequency and severity of adverse effects every cycle , from enrollment until death assesed by the NCI-CTCAE ver 3.0
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
Trial Locations
- Locations (4)
Gyeonsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Seoul St. Mary's hospital
🇰🇷Seoul, Korea, Republic of
Seoul St Mary's hospital
🇰🇷Seoul, Korea, Republic of
Severance hospital
🇰🇷Seoul, Korea, Republic of
Gyeonsang National University Hospital🇰🇷Jinju, Korea, Republic of