Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

February 14, 2015 updated by: Sook Hee Hong, The Catholic University of Korea

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Jinju, Korea, Republic of
        • Gyeonsang National University Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital
      • Seoul, Korea, Republic of, 137-040
        • Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of
        • Seoul St Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vinorelbine and Gemcitabine
Vinorelbine 25 ㎎/㎡ and Gemcibine1000㎎/㎡ D1, D8 every 3weeks
Drug: Vinorelbine and Gemcitabine
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
Other Names:
  • Gemcibine and Navelbine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (complete response and partial response)
Time Frame: 16 weeks
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
Time Frame: 6months
fom the date of enrollment until the date of confimed progressive disease or death
6months
overall survival
Time Frame: 1year
from the date of enrollment to death any cause
1year
Frequency and severity of adverse effects
Time Frame: every cycle , from enrollment until death
assesed by the NCI-CTCAE ver 3.0
every cycle , from enrollment until death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Collaborators

Korean Cancer Study Group

Investigators

  • Principal Investigator: Jae Ho Byun, Professor, Incheon St.Mary;s hospital, Catholic University of Korea
  • Principal Investigator: Sook Hee Hong, AP, Seoul St.Mary's hospital, Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 3, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 8, 2010

Study Record Updates

Last Update Posted (Estimate)

February 18, 2015

Last Update Submitted That Met QC Criteria

February 14, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCSG GY10-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on Vinorelbine and Gemcitabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe