High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery

Phase 3 Completed EBMT Solid Tumors Working Party

RandomizedTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is most effective for ovarian epithelial cancer. PURPOSE: This randomized phase III trial is studying high-dose chemotherapy to see how well it works compared to standard chemotherapy in treating patients with stage III or stage IV ovarian epithelial cancer that has been removed during surgery.

Timeline

Start: 1998-09
Primary completion: —
Completion: 2007-09

Outcome

Missed primary endpoint

paper We observed no statistically significant difference in progression-free survival or OS and conclude that HD chemotherapy does not appear to be superior to conventional dose chemotherapy. PMID 17698804 ↗

Publications

Results Mobus V, Wandt H, Frickhofen N, Bengala C, Champion K, Kimmig R, Ostermann H, Hinke A, Ledermann JA; AGO-Ovar/AIO; EBMT. Phase III trial of high-dose sequential chemotherapy with peripheral blood stem cell support compared with standard dose chemotherapy for first-line treatment of advanced ovarian cancer: intergroup trial of the AGO-Ovar/AIO and EBMT. J Clin Oncol. 2007 Sep 20;25(27):4187-93. doi: 10.1200/JCO.2006.09.7527. Epub 2007 Aug 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	—	Intravenous
Subject	Cyclophosphamide	Other / unclassified	—	Intravenous
Subject	Melphalan	Small molecule	—	Intravenous
Subject	Paclitaxel	Small molecule	—	Intravenous
Background	filgrastim	Protein / enzyme biologic	—	Subcutaneous