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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01461759

Enrollment

Registered

2011-10-28

Start date

2011-10-31

Completion date

2017-12-31

Last updated

2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Recurrent Endometrial Cancer

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.

Interventions

DRUGDoctaxel

Docetaxel 70mg/m2BSA, q 3 weeks, 8 cycles

DRUGCisplatin

Cisplatin 60mg/m2BAS, q 3 weeks, 8 cycles

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Response rate	3 months after completion of study treatment

Secondary

Measure	Time frame
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

Countries

South Korea

Contacts

Primary ContactJoo-Hyun Nam, M.D., Ph.D.

jhnam@amc.seoul.kr+82-2-3010-3633

Backup ContactJeong-Yeol Park, M.D., Ph.D.

obgyjypark@amc.seoul.kr+82-2-3010-3646

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026