Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196559
• Other study ID #: KCSG GY10-10
• Status: Completed
• Phase: Phase 2
• First received: September 3, 2010
• Last updated: February 14, 2015
• Start date: January 2011
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Cancer

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Gyeonsang National University Hospital	Jinju
Korea, Republic of	Seoul St Mary's hospital	Seoul
Korea, Republic of	Seoul St. Mary's hospital	Seoul
Korea, Republic of	Severance hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
The Catholic University of Korea	Korean Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	16 weeks	No
Secondary	Progression Free Survival	fom the date of enrollment until the date of confimed progressive disease or death	6months	No
Secondary	overall survival	from the date of enrollment to death any cause	1year	No
Secondary	Frequency and severity of adverse effects	assesed by the NCI-CTCAE ver 3.0	every cycle , from enrollment until death	Yes