Advanced or recurrent cervical cancer
Conditions
Interventions
Combination chemotherapy with nedaplatin and ifosfamide
Sponsors
Graduate School of Medicine, Chiba University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed uterine cervical cancer. 2) Clinical stage IVb and recurrent disease 3) Disease with measurable lesion according to RECIST. 4) ECOG Performance Status 0-2 5) No prior chemothrapy and radiotherapy. 6) Adequate bone marrow, cardiac, liver, lung, kidney functions. a) WBC> 3,000/mm3, b) Platelets > 100,000/mm3, c) T-Bil< 1.5 mg/dl, d) Cr< normal upper limits, e) BUN< normal upper limits, f) ECG normal. g) Expected survival more than 3months. h) Fully written informed consent.
Exclusion criteria
Exclusion criteria: 1) Severe complications: a) infections, diarrhea (watery), ileus, interstistial pneumonitis, lung fibrosis, b) massive pleural effusion or ascites, c) uncontrollable diabetes mellitus, d) other complications which suffer from progressing study. 2) Co-existence of active other malignancies. 3) Whom the investigator think unappropriate as a candidate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended dose Dose limiting toxicity Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression Overall survaival Toxicity | — |
Countries
Japan
Outcome results
None listed