Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer

Asan Medical Center

Status and phase: Unknown; Phase 2

Conditions: Advanced or Recurrent Endometrial Cancer

Treatments: Drug: Doctaxel; Drug: Cisplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01461759

ANSGOG-002

Details and patient eligibility

About

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.

Enrollment: 59 estimated patients

Sex: Female

Ages: 20 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Chemotherapy

Experimental group

Description:

Docetaxel 70mg/m2BSA + Cisplatin 60mg/m2BSA, q 3 weeks, 8cycles

Treatment:

Drug: Cisplatin

Drug: Doctaxel