Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: Boryung Pharmaceutical Co., Ltd
• Treatments: Cisplatin; Docetaxel

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.