Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

The Catholic University of Korea

Status and phase

Completed

Phase 2

Conditions

Primary Peritoneal Cancer

Fallopian Tube Cancer

Ovarian Cancer

Treatments

Drug: Vinorelbine and Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT01196559

KCSG GY10-10

Details and patient eligibility

About

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.

Full description

Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.

Enrollment

44 patients

Sex

Female

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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.