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

Phase 2
20 Years
75 Years
Open (Enrolling)
Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Thank you

Trial Information

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

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

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

- 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

- Patients had to have at least one bidimensionally measurable and/or evaluable
(unidimensionally measurable) target lesion in a non-irradiated area and increased Ca

- A >= 4 weeks interval between their last chemotherapy regimen and the start of study

- 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

- Serious comorbidities (as determined by the investigator) such as, but not limited
to, active congestive heart failure, recent myocardial infarction or active

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (complete response and partial response)

Outcome 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

Outcome Time Frame:

16 weeks

Safety Issue:


Principal Investigator

Jae Ho Byun, Associate professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Incheon St.Mary;s hospital, Catholic University of Korea


Korea: Food and Drug Administration

Study ID:

KCSG GY10-10



Start Date:

January 2011

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
  • ovarian cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms