Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Catholic University of Korea
• Collaborator: Korean Cancer Study Group
• Treatments: Gemcitabine; Vinblastine; Vinorelbine

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.