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Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01461759
Recruitment Status : Unknown
Verified May 2017 by Joo-Hyun Nam, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : October 28, 2011
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
Boryung Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced or Recurrent Endometrial Cancer Drug: Doctaxel Drug: Cisplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer
Study Start Date : October 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Response rate [ Time Frame: 3 months after completion of study treatment ]

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

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461759


Contacts
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Contact: Joo-Hyun Nam, M.D., Ph.D. +82-2-3010-3633 jhnam@amc.seoul.kr
Contact: Jeong-Yeol Park, M.D., Ph.D. +82-2-3010-3646 obgyjypark@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Joo-Hyun Nam, M.D., Ph.D    +82-2-3010-3633    jhnam@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Boryung Pharmaceutical Co., Ltd
More Information
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Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01461759    
Other Study ID Numbers: ANSGOG-002
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Diseases
Cisplatin
Antineoplastic Agents