A Phase II Study of Sorafenib and Ifosfamide as a Treatment for Patients With Sarcoma
18 Years
N/A
Both
Sarcoma
Trial Information
A Phase II Study of Sorafenib and Ifosfamide as a Treatment for Patients With Sarcoma
OBJECTIVES:
Primary
- Assess the safety, toxicity, and efficacy of neoadjuvant sorafenib tosylate and
ifosfamide in patients with resectable high-grade soft tissue or bone sarcoma.
Secondary
- Assess the long-term efficacy or impact of therapy in these patients, in terms of the
duration of local recurrence-free survival, distant recurrence-free survival, and
disease-specific survival.
OUTLINE:
- Neoadjuvant therapy: Patients receive oral sorafenib tosylate twice daily on days 1-14
in course 1. Patients then receive oral sorafenib tosylate twice daily on days 1-28 and
ifosfamide IV continuously on days 1-7 in courses 2 and 3. Treatment repeats every
14-28 days* for 3 courses.
NOTE: *Course 1 is 14 days in duration; courses 2 and 3 are 28 days in duration.
- Surgery: At least 1 week after the completion of neoadjuvant therapy, patients undergo
surgery.
- Adjuvant therapy: Beginning ≥ 3 weeks after surgery, patients who respond to
neoadjuvant therapy receive oral sorafenib twice daily for 6 months. Patients also
receive 2 courses of ifosfamide as in courses 2 and 3 of neoadjuvant therapy.
Inclusion Criteria:
- Pathologically confirmed high grade sarcoma of the soft tissue or bone
- participants Identified as a proper candidate for ifosfamide-based neoadjuvant
therapy
- candidates must have operable disease for which a resection is planned
- ECOG performance status 0-1
- Hemoglobin ≥ 9.0 g/dL
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)
- INR < 1.5 or PT/PTT normal.Concurrent anticoagulation therapy with warfarin or
heparin allowed
- Creatinine ≤ 1.5 times ULN
- women of childbearing potential must have negative pregnancy test performed within 7
days prior to start of treatment.
- Fertile patients must use effective contraception during and for ≥ 2 weeks after
completion of study therapy.
- A signed informed consent must be obtained prior to any study specific procedures.
Exclusion Criteria:
- known HIV infection
- chronic hepatitis B or C infection
- clinically active serious infection > CTCAE grade 2
- NYHA class III or IV congestive heart failure
- unstable angina (i.e., anginal symptoms at rest) or new onset angina within the past
3 months
- myocardial infarction within the past 6 months
- cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or
diastolic BP > 90 mm Hg) despite optimal medical management
- thrombolic or embolic events (e.g., cerebrovascular accident, including transient
ischemic attacks) within the past 6 months
- pulmonary hemorrhage or bleeding event ≥ CTCAE grade 2 within the past 4 weeks
- other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks
- Any condition that would impair the ability to swallow whole pills
- malabsorption problem
- Any known severe hypersensitivity to sorafenib tosylate or any of its excipients
- known or suspected allergy to sorafenib tosylate or any agent given in this study
- serious nonhealing wound, ulcer, or bone fracture
- evidence or history of bleeding diathesis or coagulopathy
- significant traumatic injury within the past 4 weeks
- major surgery or open biopsy within 4 weeks of starting treatment
- Concomitant St. John's wort or rifampin
- KNown brain metastases. Patients with neurological symptoms must undergo a CT
scan/MRI of the brain to exclude brain metastases.
- any condition that impairs patients' ability to swallow pills
- any malabsorption problem
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Using PET/CT Scan to Measure Safety, Toxicity, and Efficacy of Neoadjuvant Sorafenib Tosylate and Ifosfamide in Patients With Resectable High-grade Soft Tissue or Bone Sarcoma.
Outcome Description:
After cycle 1, a limited PET/CT scan of the affected site will be performed to assess response to sorafenib treatment alone. After cycle 3, prior to surgery, a limited PET/CT scan of the affected site will be performed to assess response to the combination sorafenib and ifosfamide treatment.
Outcome Time Frame:
Participants were followed for duration of study, an average of 1 year.
Safety Issue:
Yes
Principal Investigator
William Tap, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000633030
NCT ID:
NCT00880542
Start Date:
August 2008
Completion Date:
Related Keywords:
- Sarcoma
- localized osteosarcoma
- stage II adult soft tissue sarcoma
- stage III adult soft tissue sarcoma
- Sarcoma
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
