Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

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

Official Title
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A Phase II Study of Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Epithelial Ovarian/Fallopian Tube/ Primary Peritoneal Carcinoma.

Conditions
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Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Intervention / Treatment
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* Drug: Vinorelbine and Gemcitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vinorelbine and Gemcitabine<br>Vinorelbine 25 ㎎/㎡ and Gemcibine1000㎎/㎡ D1, D8 every 3weeks | Drug: Vinorelbine and Gemcitabine<br>* Gmcitabine 1000㎎/㎡ mix in normal saline 100ml iv for 30min andVinorelbine 25㎎/㎡ mix in normal saline 50 ml iv for 5-10min on D1 and 8 every 21 days cycle<br>* Other names: Gemcibine and Navelbine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (complete response and partial response) | radiologically assessed response every two cycles, according to RECIST ver 1.1 criteria and serologically assessed CA 125 response every two cycles, according to Rustin's criteria | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | fom the date of enrollment until the date of confimed progressive disease or death | 6months | 
| overall survival | from the date of enrollment to death any cause | 1year | 
| Frequency and severity of adverse effects | assesed by the NCI-CTCAE ver 3.0 | every cycle , from enrollment until death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian cancer