Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer
A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer
1 other identifier
interventional
59
1 country
1
Brief Summary
The purpose of this study is to treat advanced or recurrent endometrial cancer, paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by most physicians. Docetaxel may have similar efficacy and more favorable treatment related toxicity profile as tested in epithelial ovarian cancer trials. Therefore, the investigators aimed to evaluate the efficacy and safety of docetaxel plus cisplatin in patients with advanced or recurrent endometrial cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 25, 2011
CompletedFirst Posted
Study publicly available on registry
October 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 31, 2017
May 1, 2017
6.2 years
October 25, 2011
May 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Response rate
3 months after completion of study treatment
Secondary Outcomes (3)
Progression-free survival
2 years after completion of study treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Before each chemotherapy, an expected average of 3 weeks
Quality of life
3 months after completion of study treatment
Study Arms (1)
Chemotherapy
EXPERIMENTALDocetaxel 70mg/m2BSA + Cisplatin 60mg/m2BSA, q 3 weeks, 8cycles
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed chemotherapy naïve endometrial cancer
- One of following histology Endometrioid, UPSC, CCCa, squamous, adenosquamous, mixed
- FIGO stage IVb or recurrent endometrial cancer (incurable by surgery and/or RT)
- At least one measurable lesion by RECIST on CT
- ECOG PS: 0-2
- Age: 20-75
- Adequate organ function BM: ANC≥1,000/mm3, Plt≥100X103/mm3 Kidney: Creatinine\<1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT\< 3×UNL, T- bil\<1.5 mg/ mm3
- Informed Consent
- Contraception during study period
You may not qualify if:
- Previous chemotherapy
- RT, hormone therapy, or immunotherapy within 1 month
- Other malignant disease
- Uncontrolled medical disease
- Infection requiring antibiotics
- Symptomatic CHF, RF, Angina, Arrhythmia, etc.
- Neurosis or psychosis
- Pregnancy, breast-feeding
- Etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asan Medical Centerlead
- Boryung Pharmaceutical Co., Ltdcollaborator
Study Sites (1)
Asan Medical Center
Seoul, 138-736, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 25, 2011
First Posted
October 28, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
May 31, 2017
Record last verified: 2017-05