Clinical Trials Directory

Trials / Completed

CompletedNCT00720174

Cixutumumab and Doxorubicin Hydrochloride in Treating Patients With Unresectable, Locally Advanced, or Metastatic Soft Tissue Sarcoma

A Phase 1 Study of Doxorubicin and A12 in Advanced Soft Tissue Sarcoma

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
30 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

This phase I trial is studying the side effects and best dose of cixutumumab given together with doxorubicin hydrochloride and to see how well they work in treating patients with unresectable, locally advanced, or metastatic soft tissue sarcoma. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody cixutumumab together with doxorubicin hydrochloride may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To collect safety data about the combination of doxorubicin and Cixitumumab and determine if they can be combined with acceptable toxicity at full doses. SECONDARY OBJECTIVES: I. To assess the confirmed response rate (CR + PR as defined by RECIST) of patients with locally advanced or metastatic soft tissue sarcoma when treated with combination doxorubicin and Cixitumumab II. To assess the 3 and 6 month progression free survival rate of patients treated with doxorubicin and Cixitumumab. III. To assess the progression free survival and overall survival of patients treated with doxorubicin and Cixitumumab. IV. To evaluate changes in left ventricular ejection fraction assessed by MUGA scan after 2, 4 and 6 cycles of therapy compared to baseline. OUTLINE: This is a multicenter, dose-escalation study of anti-IGF-1R recombinant monoclonal antibody cixutumumab. Patients receive cixutumumab intravenously (IV) over 1 hour on days 1, 8, and 15 and doxorubicin hydrochloride IV continuously over 44-52 hours beginning on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue to receive cixutumumab in the absence of disease progression or unacceptable toxicity.

Conditions

Interventions

TypeNameDescription
BIOLOGICALCixutumumabGiven IV
DRUGDoxorubicin HydrochlorideGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies

Timeline

Start date
2008-06-01
Primary completion
2013-01-01
First posted
2008-07-22
Last updated
2016-05-17

Locations

13 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00720174. Inclusion in this directory is not an endorsement.