Phase 2
N=15
Sorafenib in Treating Patients With Soft Tissue Sarcomas (Extremity Sarcoma Closed to Entry as of 5/30/07)
Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor · Metastatic Osteosarcoma · Recurrent Adult Soft Tissue Sarcoma · Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor · Recurrent Osteosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00330421 ↗Enrolled (actual)
15
Serious AEs
73.3%
Results posted
Mar 2014
Primary outcome: Primary: Change in Fludeoxyglucose (FDG) Uptake (Maximal Standardized Uptake Value, or SUVmax)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sorafenib tosylate (Drug); therapeutic conventional surgery (Procedure); laboratory biomarker analysis (Other); pharmacological study (Other); computed tomography (Procedure); dynamic contrast-enhanced magnetic resonance imaging (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fludeoxyglucose (FDG) Uptake (Maximal Standardized Uptake Value, or SUVmax) |
— | — |
| PRIMARY Change in Interstitial Fluid Pressure (IFP) |
4.25 | — |
| PRIMARY Change in White Blood Cell Count (WBC) |
— | — |
| PRIMARY Change in Pericyte Coverage of Endothelial Cells (Alpha-SMA) |
— | — |
| PRIMARY Clinical Benefit as Measured by 50% Reduction in IFP |
— | — |
| PRIMARY Clinical Benefit, Measured by Any Reduction in Tumor Dimensions on CT Scan as Measured by RECIST Criteria |
— | — |
| PRIMARY Incidence of Adverse Events |
— | — |
Summary
This phase II trial is studying how well sorafenib works in treating patients with soft tissue sarcoma. Sorafenib may stop the growth of soft tissue sarcoma by blocking blood flow to the tumor and blocking some of the enzymes needed for tumor cell growth
Eligibility Criteria
Inclusion Criteria
- There are two groups of patients eligible for this study; treatment group 1 consists of patients with extremity sarcomas other than potentially curable osteosarcoma or Ewing's sarcoma who are candidates for potentially curative surgery; treatment group 2 consists of patients with metastatic or inoperable sarcoma, for which there is no known curative or survival prolonging palliative therapy, or failure of these therapies; patients must have at least one site of measurable disease by radiologic imaging techniques; patients must have at least one palpable tumor mass with no overlying viscera which is amenable to biopsy; the tumor mass should be approximately 2 cm or greater in diameter; patients with smaller palpable tumors are eligible if participation is approved by the treating surgeon after discussion with the study chairperson
- As of 5/30/07, no subjects will accrue to Treatment Group I
- Life expectancy >= 2 months
- Eastern Cooperative Oncology Group (ECOG) performance status = = 1,500/mm^3
- Platelets >= 100,000/mm^3
- Serum glutamic oxaloacetic transaminase (SGOT) = = 3 weeks since major surgery unrelated to study disease (sarcoma)
- >= 3 weeks since chemotherapy or radiation therapy (6 weeks for nitrosourea or mitomycin C chemotherapy)
- No prior treatment with sorafenib (BAY 43-9006) or specific inhibitors of mitogen-activated protein kinase (MAPK) pathways are permitted; a previously irradiated tumor site cannot be used for clinical or correlative measurements, although irradiation to sites other than a measurable site is permitted; there are no limitations on the extent or type of prior therapy received by the patient other than the time intervals indicated in the above and demonstrating complete recovery from any adverse effects associated by satisfying all relevant eligibility criteria
- Patients who are on warfarin anticoagulation are allowed to participate as long as they are converted to a low molecular weight heparin (e.g. lovenox) from study entry until at least day 56
- Women of childbearing potential must not be pregnant or lactating; all women of childbearing potential (age 1 gm/24 hr (does not require quantitation in absence of clinical indication)
- Patients receiving other investigational agents
- Human immunodeficiency virus (HIV) patients receiving combination anti-retroviral therapy are excluded because of potential pharmacokinetic interactions
Data sourced from ClinicalTrials.gov (NCT00330421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.