Status:
COMPLETED
Sorafenib, Epirubicin, Ifosfamide, and Radiation Therapy Followed By Surgery in Treating Patients With High-Risk Stage II or Stage III Soft Tissue Sarcoma
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
15-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as epirubicin a...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose of sorafenib tosylate when combined with epirubicin hydrochloride, ifosfamide, and hypofractionated radiotherapy prior to surgery in pat...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed soft tissue sarcoma of the upper (including shoulder) or lower (including hip) extremities or body wall
- Stage II or III disease, as defined by the following:
- Tumor dimension \> 5 cm
- Superficial or deep tumor
- Intermediate or high-grade disease
- No regional lymph node involvement
- No distant metastases
- No rhabdomyosarcoma, Ewing sarcoma, primitive neuroectodermal tumor (PNET), osteosarcoma, or gastrointestinal stromal tumor
- Pleomorphic rhabdomyosarcoma allowed
- No known metastases
- Patients with neurological symptoms must undergo a CT scan or MRI of the brain to exclude brain metastases
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Absolute Neutrophil Count (ANC) ≥ 1,500/μL
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 100,000/μL
- International Normalized Ratio (INR) \< 1.5 or Prothrombin Time/Partial Thromboplastin Time (PT/PTT) normal
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 mg/dL
- Aspartate Aminotransferase/Alanine Aminotransferase (AST/ALT) ≤ 1.5 times ULN
- Left Ventricular Ejection Fraction (LVEF) ≥ 50%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception (male patients must use effective contraception for ≥ 3 months after completion of study treatment)
- No contraindications to limb-sparing surgery
- No severe peripheral vascular disease
- No concurrent uncontrolled illness including, but not limited to, the following:
- Ongoing or active serious infection \> Common Toxicity Criteria for Adverse Effects (CTCAE) grade 2
- Symptomatic congestive heart failure
- Unstable angina pectoris (i.e., angina symptoms at rest) or new onset angina within the past 3 months
- Myocardial infarction within the past 6 months
- Cardiac ventricular arrhythmia requiring anti-arrhythmic therapy
- Psychiatric illness/social situation that would limit compliance with study requirements
- No uncontrolled hypertension (defined as systolic blood pressure \> 150 mm Hg or diastolic blood pressure \> 90 mm Hg, despite optimal medical management)
- No known HIV infection or chronic hepatitis B or C infection
- No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
- No pulmonary hemorrhage or bleeding event ≥ CTCAE grade 2 within the past 4 weeks
- No other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks
- No serious non-healing wound, ulcer, or bone fracture
- No evidence or history of bleeding diathesis or coagulopathy
- No significant traumatic injury within the past 4 weeks
- No known or suspected allergy to sorafenib tosylate or any agent given in the study
- No condition that would impair the ability to swallow whole pills
- No malabsorption problem
- No "currently active" second malignancy other than non-melanoma skin cancer
- Not considered to have a "currently active" malignancy if patient completed therapy AND has a \< 30% risk of relapse
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or biotherapy
- More than 4 weeks since prior major surgery
- No concurrent St. John's wort or rifampin
- No other concurrent investigational or anticancer therapy
- Concurrent anticoagulation with warfarin or heparin allowed
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00822848
Start Date
February 1 2009
End Date
April 30 2013
Last Update
September 7 2018
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098