Brief Title
Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer
Official Title
A Phase II Study of Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Epithelial Ovarian/Fallopian Tube/ Primary Peritoneal Carcinoma.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective response rate (complete response and partial response)
Secondary Outcome
Progression Free Survival
Condition
Ovarian Cancer
Intervention
Vinorelbine and Gemcitabine
Study Arms / Comparison Groups
Vinorelbine and Gemcitabine
Description: Vinorelbine 25 ㎎/㎡ and Gemcibine1000㎎/㎡ D1, D8 every 3weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
44
Start Date
January 2011
Completion Date
October 2014
Primary Completion Date
October 2014
Eligibility Criteria
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.
Gender
Female
Ages
20 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Jae Ho Byun, Professor, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01196559
Organization ID
KCSG GY10-10
Responsible Party
Principal Investigator
Study Sponsor
The Catholic University of Korea
Collaborators
Korean Cancer Study Group
Study Sponsor
Jae Ho Byun, Professor, Principal Investigator, Incheon St.Mary;s hospital, Catholic University of Korea
Verification Date
February 2015