drugset / Trial / NCT00063999

Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer

NCT00063999

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase III trial compares how well two different combination chemotherapy regimens (doxorubicin hydrochloride, cisplatin, and paclitaxel versus carboplatin and paclitaxel) work in treating patients with endometrial cancer that is stage III-IV or has come back (recurrent). Drugs used in chemotherapy such as doxorubicin hydrochloride, cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known which combination chemotherapy regimen is more effective in treating endometrial cancer.

Timeline

Start
2003-08-25
Primary completion
2013-06-29
Completion
2021-01-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule Intravenous
Comparator Cisplatin Other / unclassified 50 mg/m2 Intravenous
Comparator Doxorubicin Other / unclassified 45 mg/m2 Intravenous
Subject Paclitaxel Small molecule 160 mg/m2 Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Comparator Pegfilgrastim Protein / enzyme biologic Subcutaneous
Comparator filgrastim Protein / enzyme biologic Subcutaneous

Indications