advanced or recurrent endometrial carcinoma
Conditions
Interventions
Docetaxel 70mg/m2+CDDP 60mg/m2 day1 q 3 weeks 3courses or more
Docetaxel 60mg/m2+CBDCA AUC 6 day1 q 3 weeks 3courses or more
Paclitaxel 180mg/m2+CBDCA AUC 6 day1 q 3 weeks 3courses or more
Sponsors
Japanese Gynecologic Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: -Histologically confirmed endometrial carcinoma -Stage III, IV, or recurrent disease -Measurable disease -At least 1 uni-dimensional measurable lesion >= 20 mm by conventional CT or MR OR >= 10 mm by helical CT scan -At least 1 target lesion -Prior therapy: *At least 6 months since prior cytotoxic chemotherapy *At least 4 weeks since prior radiotherapy *At least 2 weeks since prior oral fluorouracil, hormonal or immunologic therapy -Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 -Adequate bone marrow, hepatic, renal, cardiac and respiratory functions -Written informed consent
Exclusion criteria
Exclusion criteria: -Patients with sarcomatous element -Active infections -Serious complications (heart disease, interstitial lung disease, uncontrolled hypertension, diabetes mellitus and tendency to bleeding) -Massive pleural effusion or ascites -Neuropathy grade 2 or more; edema grade 2 or more (NCI-CTC) -Active concomitant malignancy -Hypersensitivity to Polysorbate 80 or Cremophor EL -Patients judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Response | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity, Feasibility, Progression free survival | — |
Countries
Japan
Contacts
Public ContactDaisuke Aoki, M.D.
JGOG2041 Coordinating Office Department of Obstetrics and Gynecology, School of Medicine, Keio University
Outcome results
None listed