Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by The Catholic University of Korea.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Korean Cancer Study Group
Information provided by (Responsible Party):
Sook Hee Hong, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01196559
First received: September 3, 2010
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Drug: Gemcitabine
Drug: Vinorelbine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Epithelial Ovarian/Fallopian Tube/ Primary Peritoneal Carcinoma.

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Objective response rate (complete response and partial response) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6months ] [ Designated as safety issue: No ]
    fom the date of enrollment until the date of confimed progressive disease or death

  • overall survival [ Time Frame: 1year ] [ Designated as safety issue: No ]
    from the date of enrollment to death any cause

  • Frequency and severity of adverse effects [ Time Frame: every cycle , from enrollment until death ] [ Designated as safety issue: Yes ]
    assesed by the NCI-CTCAE ver 3.0


Estimated Enrollment: 44
Study Start Date: January 2011
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gemcitabine
    1000㎎/㎡ mix in normal saline 100ml iv for 30min on D1 and 8 every 21 days cycle
    Other Name: Gemcibine
    Drug: Vinorelbine
    25㎎/㎡ mix in normal saline 50 ml iv for 5-10min on D1 and 8 every 21 days cycle
    Other Name: Navelbine
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196559

Contacts
Contact: Sook Hee Hong, Assistant professor 82-2-2258-6045 ssuki76@catholic.ac.kr

Locations
Korea, Republic of
Gyeonsang National University Hospital Recruiting
Jinju, Korea, Republic of
Seoul St. Mary's hospital Not yet recruiting
Seoul, Korea, Republic of, 137-040
Contact: Sook Hee Hong, Assistant professor    82-2258-6045    ssuki76@catholic.ac.kr   
Seoul St Mary's hospital Recruiting
Seoul, Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
The Catholic University of Korea
Korean Cancer Study Group
Investigators
Principal Investigator: Jae Ho Byun, Associate professor Incheon St.Mary;s hospital, Catholic University of Korea
Principal Investigator: Sook Hee Hong, Assistant professor Seoul St.Mary's hospital, Catholic University of Korea
  More Information

No publications provided

Responsible Party: Sook Hee Hong, Division of Medical Oncology, Multidisciplinary team of Gynecologic cancer, Seoul St. Mary's hospital, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01196559     History of Changes
Other Study ID Numbers: KCSG GY10-10
Study First Received: September 3, 2010
Last Updated: February 22, 2012
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Gemcitabine
Vinorelbine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on April 14, 2014