Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by The Catholic University of Korea.
Recruitment status was Recruiting
Korean Cancer Study Group
Information provided by (Responsible Party):
Sook Hee Hong, The Catholic University of Korea
First received: September 3, 2010
Last updated: February 22, 2012
Last verified: February 2012
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.
Primary Peritoneal Cancer
Fallopian Tube Cancer
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Study of Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Epithelial Ovarian/Fallopian Tube/ Primary Peritoneal Carcinoma.
Primary Outcome Measures:
Secondary Outcome Measures:
- Progression Free Survival [ Time Frame: 6months ] [ Designated as safety issue: No ]
fom the date of enrollment until the date of confimed progressive disease or death
- overall survival [ Time Frame: 1year ] [ Designated as safety issue: No ]
from the date of enrollment to death any cause
- Frequency and severity of adverse effects [ Time Frame: every cycle , from enrollment until death ] [ Designated as safety issue: Yes ]
assesed by the NCI-CTCAE ver 3.0
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||September 2013 (Final data collection date for primary outcome measure)
1000㎎/㎡ mix in normal saline 100ml iv for 30min on D1 and 8 every 21 days cycle
Other Name: Gemcibine
25㎎/㎡ mix in normal saline 50 ml iv for 5-10min on D1 and 8 every 21 days cycle
Other Name: Navelbine
Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.
|Ages Eligible for Study:
||20 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196559
|Gyeonsang National University Hospital
|Jinju, Korea, Republic of |
|Seoul St. Mary's hospital
|Seoul, Korea, Republic of, 137-040 |
|Contact: Sook Hee Hong, Assistant professor 82-2258-6045 firstname.lastname@example.org |
|Seoul St Mary's hospital
|Seoul, Korea, Republic of |
|Seoul, Korea, Republic of |
The Catholic University of Korea
Korean Cancer Study Group
||Jae Ho Byun, Associate professor
||Incheon St.Mary;s hospital, Catholic University of Korea
||Sook Hee Hong, Assistant professor
||Seoul St.Mary's hospital, Catholic University of Korea
No publications provided
||Sook Hee Hong, Division of Medical Oncology, Multidisciplinary team of Gynecologic cancer, Seoul St. Mary's hospital, The Catholic University of Korea
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 3, 2010
||February 22, 2012
||Korea: Food and Drug Administration
Korea: Institutional Review Board
Keywords provided by The Catholic University of Korea:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 22, 2014
Fallopian Tube Neoplasms
Genital Neoplasms, Female
Neoplasms by Site
Fallopian Tube Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic