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
7 other identifiers
interventional
30
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 19, 2008
CompletedFirst Posted
Study publicly available on registry
July 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedMay 17, 2016
May 1, 2016
4.6 years
July 19, 2008
May 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Maximally tolerated dose (MTD) of cixitumumab when administered in a combination regimen with fixed dose doxorubicin hydrochloride, in patients with locally advanced or metastatic soft tissue sarcoma
The MTD is defined as the dose of Cixitumumab that induces dose-limiting toxicity (DLT) in no more than 20% of patients.
Up to 2 courses of treatment
Secondary Outcomes (4)
Changes in cardiac function as measured by MUGA scans of the left ventricular ejection fraction
Baseline to 6 courses of treatment
Confirmed response rate (CR + PR) for comparison with doxorubicin treatment in similar historical patient populations
Up to 6 months
Overall survival
Until death due to any cause, or loss to follow-up, assessed up to 6 months
Progression-free survival
Until documented disease progression or death or loss-to-follow-up, assessed up to 6 months
Study Arms (1)
Treatment (cixutumumab and doxorubicin hydrochloride)
EXPERIMENTALPatients receive cixutumumab 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.
Interventions
Given IV
Given IV
Correlative studies
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed soft tissue sarcoma
- Unresectable disease
- Locally advanced or metastatic disease
- The following tumor types are not allowed:
- Embryonal and alveolar rhabdomyosarcoma
- Gastrointestinal stromal tumor
- Alveolar soft part sarcoma
- Clear cell sarcoma
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- No more than 1 prior therapy for sarcoma
- No known brain metastases
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- ANC ≥ 1,500/µL
- Platelet count ≥ 100,000/µL
- Leukocytes ≥ 3,000/µL
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62702, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Chugh R, Griffith KA, Davis EJ, Thomas DG, Zavala JD, Metko G, Brockstein B, Undevia SD, Stadler WM, Schuetze SM. Doxorubicin plus the IGF-1R antibody cixutumumab in soft tissue sarcoma: a phase I study using the TITE-CRM model. Ann Oncol. 2015 Jul;26(7):1459-64. doi: 10.1093/annonc/mdv171. Epub 2015 Apr 9.
PMID: 25858498DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rashmi Chugh
University of Chicago Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2008
First Posted
July 22, 2008
Study Start
June 1, 2008
Primary Completion
January 1, 2013
Last Updated
May 17, 2016
Record last verified: 2016-05