Clinical trial · Interventional
Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer
A Phase II Study of Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Epithelial Ovarian/Fallopian Tube/ Primary Peritoneal Carcinoma.
NCT01196559CI-TRIAL-00016884completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vinorelbine and Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vinorelbine and Gemcitabine
- description
- Vinorelbine 25 ㎎/㎡ and Gemcibine1000㎎/㎡ D1, D8 every 3weeks
- interventionNames
- Drug: Vinorelbine and Gemcitabine
Primary outcomes (1)
- measure
- Objective response rate (complete response and partial response)
- timeFrame
- 16 weeks
- description
- 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
Secondary outcomes (3)
- measure
- Progression Free Survival
- timeFrame
- 6months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHong 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. PMID 25462205