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.
1 other identifier
interventional
44
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 ovarian-cancer
Started Jan 2011
Typical duration for phase_2 ovarian-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2010
CompletedFirst Posted
Study publicly available on registry
September 8, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFebruary 18, 2015
February 1, 2015
3.8 years
September 3, 2010
February 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate (complete response and partial response)
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
16 weeks
Secondary Outcomes (3)
Progression Free Survival
6months
overall survival
1year
Frequency and severity of adverse effects
every cycle , from enrollment until death
Study Arms (1)
Vinorelbine and Gemcitabine
EXPERIMENTALVinorelbine 25 ㎎/㎡ and Gemcibine1000㎎/㎡ D1, D8 every 3weeks
Interventions
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Catholic University of Korealead
- Korean Cancer Study Groupcollaborator
Study Sites (4)
Gyeonsang National University Hospital
Jinju, South Korea
Seoul St. Mary's hospital
Seoul, 137-040, South Korea
Seoul St Mary's hospital
Seoul, South Korea
Severance hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 25462205DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae Ho Byun, Professor
Incheon St.Mary;s hospital, Catholic University of Korea
- PRINCIPAL INVESTIGATOR
Sook Hee Hong, AP
Seoul St.Mary's hospital, Catholic University of Korea
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division of Medical Oncology, Multidisciplinary team of Gynecologic cancer, Seoul St. Mary's hospital
Study Record Dates
First Submitted
September 3, 2010
First Posted
September 8, 2010
Study Start
January 1, 2011
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
February 18, 2015
Record last verified: 2015-02