AzTrials
AzTrials

Ovarian CancerPhase 2NCT01196559

Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

A Phase 2 study testing Vinorelbine and Gemcitabine in people with Ovarian Cancer and Primary Peritoneal Cancer, run by The Catholic University of Korea at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years, women only
What is being tested?
Vinorelbine and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
4 sitesSouth Korea
Study dates
Jan 2011to Oct 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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)

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Gyeonsang National University Hospital

    Jinju

  • Seoul St. Mary's hospital

    Seoul, 137-040

  • Seoul St Mary's hospital

    Seoul

  • Severance hospital

    Seoul

Other trials in South Korea

About this study

Official title: 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.

Read the detailed description

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

Being tested
Vinorelbine and Gemcitabine
Keywords
ovarian cancer
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vinorelbine and GemcitabineDrug

    Also called Gemcibine and Navelbine

    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

Study groups in NCT01196559
Study groupRoleWhat they receive
Vinorelbine and GemcitabineExperimentalVinorelbine 25 ㎎/㎡ and Gemcibine1000㎎/㎡ D1, D8 every 3weeks
Receives: Drug: Vinorelbine and Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 16 weeks

Secondary outcomes (3)

  1. Progression Free Survival

    fom the date of enrollment until the date of confimed progressive disease or death

    Measured: 6months

  2. overall survival

    from the date of enrollment to death any cause

    Measured: 1year

  3. Frequency and severity of adverse effects

    assesed by the NCI-CTCAE ver 3.0

    Measured: every cycle , from enrollment until death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01196559
Sponsor's protocol ID
KCSG GY10-10
Status last verified
Feb 2015
First submitted
3 Sep 2010
Last updated
18 Feb 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25462205

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vinorelbine and Gemcitabine in people with Ovarian Cancer and Primary Peritoneal Cancer, run by The Catholic University of Korea at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (complete response and partial response) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01196559, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in