Status:
COMPLETED
Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer
Lead Sponsor:
The Catholic University of Korea
Collaborating Sponsors:
Korean Cancer Study Group
Conditions:
Ovarian Cancer
Primary Peritoneal Cancer
Eligibility:
FEMALE
20-75 years
Phase:
PHASE2
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 ...
Detailed Description
Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01196559
Start Date
January 1 2011
End Date
October 1 2014
Last Update
February 18 2015
Active Locations (4)
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1
Gyeonsang National University Hospital
Jinju, South Korea
2
Seoul St. Mary's hospital
Seoul, South Korea, 137-040
3
Seoul St Mary's hospital
Seoul, South Korea
4
Severance hospital
Seoul, South Korea