Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer
This study is currently recruiting participants.
Verified February 2012 by The Catholic University of Korea
Sponsor:
The Catholic University of Korea
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
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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:
Drug Information available for:
Vinorelbine
Gemcitabine
Gemcitabine hydrochloride
Vinorelbine tartrate
U.S. FDA Resources
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:
Detailed Description:
-
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
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 May 19, 2013