Brostallicin or Doxorubicin as First-Line Therapy in Treating Patients With Relapsed, Refractory, or Metastatic Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00410462|
Recruitment Status : Unknown
Verified July 2010 by European Organisation for Research and Treatment of Cancer - EORTC.
Recruitment status was: Active, not recruiting
First Posted : December 13, 2006
Last Update Posted : August 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Sarcoma Small Intestine Cancer||Drug: brostallicin Drug: doxorubicin hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|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|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||September 2008|
- Six-month progression-free survival, in terms of complete response, partial response, or no change
- Overall progression-free survival
- Objective tumor response
- Safety (CTCAE v 3.0)
- Duration of response
- Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410462
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Study Chair:||Hans Gelderblom, MD, PhD||Leiden University Medical Center|