Phase 2
N=20
Sorafenib Tosylate, Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With High-Risk Stage IIB-IV Soft Tissue Sarcoma
Pleomorphic Rhabdomyosarcoma · Stage IIB Adult Soft Tissue Sarcoma AJCC v7 · Stage III Adult Soft Tissue Sarcoma AJCC v7 · Stage IV Adult Soft Tissue Sarcoma AJCC v7
Bottom Line
View on ClinicalTrials.gov: NCT02050919 ↗Enrolled (actual)
20
Serious AEs
90.0%
Results posted
Jun 2020
Primary outcome: Primary: Pathologic Response Rate, Defined as the Percentage of Participants With Greater Than or Equal to 95% Necrosis. — 20 % of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Epirubicin Hydrochloride (Drug); External Beam Radiation Therapy (Radiation); Ifosfamide (Drug); Laboratory Biomarker Analysis (Other); Sorafenib Tosylate (Drug); Therapeutic Conventional Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OHSU Knight Cancer Institute
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Response Rate, Defined as the Percentage of Participants With Greater Than or Equal to 95% Necrosis. |
20 | — |
| SECONDARY Number of Grade 3-4 Adverse Events |
86 | — |
| SECONDARY Number of Participants With Wound Complications |
10 | — |
| SECONDARY Overall Survival at 2 Years |
82 | — |
| SECONDARY Overall Disease-free Survival (Stage IIB-III Patients) |
13.3 | — |
| SECONDARY Distant Disease-free Survival (Stage IIB-III Patients) |
16.4 | — |
| SECONDARY Number of Participants With Local Recurrence |
— | — |
Summary
This phase II trial studies how well sorafenib tosylate, combination chemotherapy, radiation therapy, and surgery work in treating patients with high-risk stage IIB-IV soft tissue sarcoma. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin hydrochloride and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x rays to kill tumor cells. Giving sorafenib tosylate, combination chemotherapy, radiation therapy, and surgery may be an effective treatment for soft tissue sarcoma.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed, soft-tissue sarcoma: excluding rhabdomyosarcoma (pleomorphic rhabdomyosarcoma patients are eligible), Ewing's, primitive neuroectodermal tumor (PNET), osteosarcoma, or gastrointestinal stromal tumor
- American Joint Committee on Cancer (AJCC) (7th edition) stage IIb, III, or IV patients planned for resection of the primary tumor
- > 5 cm in greatest dimension
- Intermediate or high-grade
- Superficial or deep
- Sarcoma located on upper (includes shoulder) or lower (includes hip) extremities or on body wall
- Intermediate or high-grade: grades 2 or 3 on scale of 1-3
- Left ventricular ejection fraction (LVEF) >= 50%
- Absolute neutrophil count (ANC) >= 1500/uL
- Hemoglobin (Hgb) >= 9.0 g/dL
- Platelets >= 100,000/uL
- Creatinine = Common Terminology Criteria for Adverse Events (CTCAE) grade 2, symptomatic congestive heart failure, unstable angina pectoris, cardiac ventricular arrhythmia requiring anti-arrhythmic therapy, or psychiatric illness/social situations that would limit compliance with study requirements; patients must not have unstable angina (angina symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
- Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
- Pulmonary hemorrhage/bleeding event >= CTCAE grade 2 within 4 weeks of first dose of study drug
- Any other hemorrhage/bleeding event >= CTCAE grade 3 within 4 weeks of first dose of study drug
- Serious non-healing wound, ulcer, or bone fracture
- Evidence or history of bleeding diathesis or coagulopathy
- Major surgery or significant traumatic injury within 4 weeks of first study drug
- Use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers
- Known or suspected allergy to sorafenib or any agent given in the course of this trial
- Any condition that impairs patient's ability to swallow whole pills
- Any malabsorption problem
- Pregnant or lactating women are excluded from this study
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered; patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse
- Any uncontrolled thyroid disease
- Requirement for hemodialysis or peritoneal dialysis
Data sourced from ClinicalTrials.gov (NCT02050919). 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.