Brostallicin or Doxorubicin as First-Line Therapy in Treating Patients With Relapsed, Refractory, or Metastatic Soft Tissue Sarcoma

Phase 2

• Conditions: Ovarian Cancer; Sarcoma; Small Intestine Cancer

• Registration Number: NCT00410462
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* 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 Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-12-11
• Study First Submitted QC: 2006-12-11
• Study First Posted: 2006-12-13
• Primary Completion: 2008-09
• Status Verified: 2010-07
• Last Update Submitted: 2014-08-07
• Last Update Posted: 2014-08-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Six-month progression-free survival, in terms of complete response, partial response, or no change

Secondary Outcome Measures

Name	Time	Method
Objective tumor response
Duration of response
Overall progression-free survival
Overall survival
Safety (CTCAE v 3.0)

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands