Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer

May 27, 2017 updated by: Joo-Hyun Nam, Asan Medical Center

A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemotherapy
Docetaxel 70mg/m2BSA + Cisplatin 60mg/m2BSA, q 3 weeks, 8cycles
Drug: Doctaxel
Docetaxel 70mg/m2BSA, q 3 weeks, 8 cycles
Drug: Cisplatin
Cisplatin 60mg/m2BAS, q 3 weeks, 8 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: 3 months after completion of study treatment
3 months after completion of study treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 2 years after completion of study treatment
2 years after completion of study treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Before each chemotherapy, an expected average of 3 weeks
Before each chemotherapy, an expected average of 3 weeks
Quality of life
Time Frame: 3 months after completion of study treatment
3 months after completion of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Boryung Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 27, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANSGOG-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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