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Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

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

NCT01196559•The Catholic University of Korea

View on ClinicalTrials.gov

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.

Detailed Description

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

Eligibility

Age

20 - 75 years

Sex

FEMALE

Healthy Volunteers

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
+2 more criteria

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.

Locations (4)

Gyeonsang National University Hospital

Jinju, South Korea

Seoul St. Mary's hospital

Seoul, South Korea

Seoul St Mary's hospital

Seoul, South Korea

Severance hospital

Seoul, South Korea

Key Dates

Start Date

January 1, 2011

Primary Completion Date

October 1, 2014

Completion Date

October 1, 2014

Last Updated

February 18, 2015

Enrollment

ACTUAL participants

Conditions

Ovarian CancerPrimary Peritoneal CancerFallopian Tube Cancer

Interventions

Vinorelbine and Gemcitabine

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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