A Phase II Study of Sorafenib and Ifosfamide as a Treatment for Patients With Sarcoma
- Assess the safety, toxicity, and efficacy of neoadjuvant sorafenib tosylate and
ifosfamide in patients with resectable high-grade soft tissue or bone sarcoma.
- 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
- 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
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
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.
Participants were followed for duration of study, an average of 1 year.
William Tap, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|