Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by Asan Medical Center
Sponsor:
Collaborator:
Boryung Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01461759
First received: October 25, 2011
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Advanced or Recurrent Endometrial Cancer
Drug: Doctaxel
Drug: Cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Response rate [ Time Frame: 3 months after completion of study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 2 years after completion of study treatment ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Before each chemotherapy, an expected average of 3 weeks ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 3 months after completion of study treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 59
Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461759

Contacts
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
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

No publications provided

Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01461759     History of Changes
Other Study ID Numbers: ANSGOG-002
Study First Received: October 25, 2011
Last Updated: October 27, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 19, 2014