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Trial record 83 of 526 for:    "Primary Peritoneal Carcinoma"

Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01196559
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : February 18, 2015
Korean Cancer Study Group
Information provided by (Responsible Party):
Sook Hee Hong, The Catholic University of Korea

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer Drug: Vinorelbine and Gemcitabine Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : January 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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 Name: Gemcibine and Navelbine

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 6months ]
    fom the date of enrollment until the date of confimed progressive disease or death

  2. overall survival [ Time Frame: 1year ]
    from the date of enrollment to death any cause

  3. Frequency and severity of adverse effects [ Time Frame: every cycle , from enrollment until death ]
    assesed by the NCI-CTCAE ver 3.0

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01196559

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Korea, Republic of
Gyeonsang National University Hospital
Jinju, Korea, Republic of
Seoul St. Mary's hospital
Seoul, Korea, Republic of, 137-040
Seoul St Mary's hospital
Seoul, Korea, Republic of
Severance hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
The Catholic University of Korea
Korean Cancer Study Group
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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 automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sook Hee Hong, Division of Medical Oncology, Multidisciplinary team of Gynecologic cancer, Seoul St. Mary's hospital, The Catholic University of Korea Identifier: NCT01196559     History of Changes
Other Study ID Numbers: KCSG GY10-10
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015

Keywords provided by Sook Hee Hong, The Catholic University of Korea:
ovarian cancer

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic