Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer
NCT ID: NCT01196559
Last Updated: 2015-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2011-01-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vinorelbine and Gemcitabine
Vinorelbine 25 ㎎/㎡ and Gemcibine1000㎎/㎡ D1, D8 every 3weeks
Vinorelbine 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
Interventions
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Vinorelbine 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
75 Years
FEMALE
No
Sponsors
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Korean Cancer Study Group
OTHER
The Catholic University of Korea
OTHER
Responsible Party
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Sook Hee Hong
Division of Medical Oncology, Multidisciplinary team of Gynecologic cancer, Seoul St. Mary's hospital
Principal Investigators
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Jae Ho Byun, Professor
Role: PRINCIPAL_INVESTIGATOR
Incheon St.Mary;s hospital, Catholic University of Korea
Sook Hee Hong, AP
Role: PRINCIPAL_INVESTIGATOR
Seoul St.Mary's hospital, Catholic University of Korea
Locations
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Gyeonsang National University Hospital
Jinju, , South Korea
Seoul St. Mary's hospital
Seoul, , South Korea
Seoul St Mary's hospital
Seoul, , South Korea
Severance hospital
Seoul, , South Korea
Countries
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References
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Hong SH, Lee S, Kim HG, Lee HJ, Jung KH, Lee SC, Lee NR, Yun J, Woo IS, Park KH, Kim KH, Kim HY, Rha SY, Byun JH. Phase II study of gemcitabine and vinorelbine as second- or third-line therapy in patients with primary refractory or platinum-resistant recurrent ovarian and primary peritoneal cancer by the Korean Cancer Study Group (KCSG)_KCSG GY10-10. Gynecol Oncol. 2015 Feb;136(2):212-7. doi: 10.1016/j.ygyno.2014.11.017. Epub 2014 Nov 22.
Other Identifiers
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KCSG GY10-10
Identifier Type: -
Identifier Source: org_study_id
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