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Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

Primary Purpose

Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vinorelbine and Gemcitabine
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Gyeonsang National University Hospital
  • Seoul St. Mary's hospital
  • Seoul St Mary's hospital
  • Severance hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vinorelbine and Gemcitabine

Arm Description

Vinorelbine 25 ㎎/㎡ and Gemcibine1000㎎/㎡ D1, D8 every 3weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression Free Survival
fom the date of enrollment until the date of confimed progressive disease or death
overall survival
from the date of enrollment to death any cause
Frequency and severity of adverse effects
assesed by the NCI-CTCAE ver 3.0

Full Information

First Posted
September 3, 2010
Last Updated
February 14, 2015
Sponsor
The Catholic University of Korea
Collaborators
Korean Cancer Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT01196559
Brief Title
Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer
Official Title
A Phase II Study of Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Epithelial Ovarian/Fallopian Tube/ Primary Peritoneal Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
Collaborators
Korean Cancer Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
Keywords
ovarian cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vinorelbine and Gemcitabine
Arm Type
Experimental
Arm Description
Vinorelbine 25 ㎎/㎡ and Gemcibine1000㎎/㎡ D1, D8 every 3weeks
Intervention Type
Drug
Intervention Name(s)
Vinorelbine and Gemcitabine
Other Intervention Name(s)
Gemcibine and Navelbine
Intervention Description
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
Primary Outcome Measure Information:
Title
Objective response rate (complete response and partial response)
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
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
fom the date of enrollment until the date of confimed progressive disease or death
Time Frame
6months
Title
overall survival
Description
from the date of enrollment to death any cause
Time Frame
1year
Title
Frequency and severity of adverse effects
Description
assesed by the NCI-CTCAE ver 3.0
Time Frame
every cycle , from enrollment until death

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Ho Byun, Professor
Organizational Affiliation
Incheon St.Mary;s hospital, Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sook Hee Hong, AP
Organizational Affiliation
Seoul St.Mary's hospital, Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gyeonsang National University Hospital
City
Jinju
Country
Korea, Republic of
Facility Name
Seoul St. Mary's hospital
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of
Facility Name
Seoul St Mary's hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25462205
Citation
Hong 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.
Results Reference
derived

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Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

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