Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen.
Timeline
- Start
- 2002-05
- Primary completion
- 2004-01
- Completion
- —
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
paper The primary end-point was overall response rate (ORR) as defined by response evaluation criteria in solid tumours (RECIST). PMID 17095209 ↗
paper In the GIST group, no patients had a confirmed response and recruitment was discontinued at the first step. PMID 17095209 ↗
paper In the non-GIST group, there were two confirmed partial responses. PMID 17095209 ↗
Publications
- Results Leahy M, Ray-Coquard I, Verweij J, Le Cesne A, Duffaud F, Hogendoorn PC, Fowst C, de Balincourt C, di Paola ED, van Glabbeke M, Judson I, Blay JY; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Brostallicin, an agent with potential activity in metastatic soft tissue sarcoma: a phase II study from the European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2007 Jan;43(2):308-15. doi: 10.1016/j.ejca.2006.09.014. Epub 2006 Nov 13.
- Results Leahy MG, Blay JY, Verweij J, et al.: EORTC 62011: phase II trial of brostallicin for soft tissue sarcoma. [Abstract] Eur J Cancer Suppl 1 (5): S209, A-694, 2003.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | brostallicin | Other / unclassified | 10 mg/m2 | Intravenous |