Status:
COMPLETED
Cixutumumab and Doxorubicin Hydrochloride in Treating Patients With Unresectable, Locally Advanced, or Metastatic Soft Tissue Sarcoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Angiosarcoma
Adult Desmoplastic Small Round Cell Tumor
Eligibility:
All Genders
16+ years
Phase:
PHASE1
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...
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:...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Total bilirubin ≤ upper limit of normal(ULN)
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- Fasting serum glucose \< 120 mg/dL OR below ULN
- LVEF ≥ 50% by MUGA scan
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after the last dose of anti-IGF-1R recombinant monoclonal antibody IMC-A12
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to anti-IGF-1R recombinant monoclonal antibody IMC-A12
- No poorly controlled diabetes mellitus
- Patients with a history of diabetes mellitus are eligible provided their blood glucose is within normal range and they are on a stable dietary or therapeutic regimen for this condition
- No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would preclude compliance with study requirements
- No other concurrent investigational or commercial agents or therapies
- Recovered from all prior therapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- More than 4 weeks since prior major surgery, hormonal therapy (other than replacement), or hormonal therapy
- No prior radiotherapy to the heart, mediastinum, or chest wall
- No prior anthracycline therapy or anti-IGF-1R therapy
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00720174
Start Date
June 1 2008
Last Update
May 17 2016
Active Locations (13)
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1
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
2
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
3
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
4
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426