Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01196559
• Date of registration: 03/09/2010
• Primary sponsor: The Catholic University of Korea
• Public title: Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer
• Scientific title: A Phase II Study of Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Epithelial Ovarian/Fallopian Tube/ Primary Peritoneal Carcinoma.
• Date of first enrolment: January 2011
• Target sample size: 44
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01196559
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Korea, Republic of

Contacts

• Name: Sook Hee Hong, Assistant professor

• Name: Sook Hee Hong, Assistant professor

• Name: Jae Ho Byun, Associate professor
• Affiliation: Incheon St.Mary;s hospital, Catholic University of Korea

• Name: Sook Hee Hong, Assistant professor
• Affiliation: Seoul St.Mary's hospital, Catholic University of Korea

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Fallopian Tube Cancer

Ovarian Cancer

Primary Peritoneal Cancer

Intervention(s)

Drug: Gemcitabine

Drug: Vinorelbine

Primary Outcome(s)

Objective response rate (complete response and partial response) [Time Frame: 16 weeks]

Secondary Outcome(s)

Frequency and severity of adverse effects [Time Frame: every cycle , from enrollment until death]

overall survival [Time Frame: 1year]

Progression Free Survival [Time Frame: 6months]

Secondary ID(s)

KCSG GY10-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Korean Cancer Study Group