Clinical trial NCT01196559: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Keywords: ovarian cancer
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Korean Cancer Study Group
First posted: 2010-09-08
Enrollment: 44
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective response rate (complete response and partial response)
timeFrame: 16 weeks
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 6months
measure: overall survival
timeFrame: 1year
measure: Frequency and severity of adverse effects
timeFrame: every cycle , from enrollment until death
Other outcomes:
Locations:
city: Jinju
country: Korea, Republic of
facility: Gyeonsang National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's hospital
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
affiliation: Incheon St.Mary;s hospital, Catholic University of Korea
name: Jae Ho Byun, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul St.Mary's hospital, Catholic University of Korea
name: Sook Hee Hong, AP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.