Brostallicin or Doxorubicin as First-Line Therapy in Treating Patients With Relapsed, Refractory, or Metastatic Soft Tissue Sarcoma
RATIONALE: Drugs used in chemotherapy, such as brostallicin and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This randomized phase II trial is studying the side effects and how well brostallicin or doxorubicin works as first-line therapy in treating patients with relapsed, refractory, or metastatic soft tissue sarcoma.
Small Intestine Cancer
Drug: doxorubicin hydrochloride
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Study of Brostallicin (PNU-166196A) Versus Doxorubicin as First Line Chemotherapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma|
- Six-month progression-free survival, in terms of complete response, partial response, or no change [ Designated as safety issue: No ]
- Overall progression-free survival [ Designated as safety issue: No ]
- Objective tumor response [ Designated as safety issue: No ]
- Safety (CTCAE v 3.0) [ Designated as safety issue: Yes ]
- Duration of response [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
- Determine the activity and safety of brostallicin vs doxorubicin hydrochloride as first-line therapy in patients with relapsed, refractory, or metastatic soft tissue sarcoma.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating and age(younger than 60 years vs 60 years and over). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive brostallicin IV over 10 minutes on day 1.
- Arm II: Patients receive doxorubicin hydrochloride IV over 10 minutes on day 1. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.
PROJECTED ACCRUAL: A total of 108 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410462
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Study Chair:||Hans Gelderblom, MD, PhD||Leiden University Medical Center|