Anti-Angiogenic Chemotherapy: A Phase II Trial of Thalidomide, Celecoxib, Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer
- Thalidomide will be given orally every evening and the daily dose will escalate until
the patient reaches a dose on which they are comfortable and will given continuously
for one year.
- Celecoxib will be given orally twice a day and escalated as tolerated for one year.
- Etoposide will be given orally once a day for 21 consecutive days. This medication
will alternate with oral cyclophosphamide and will continue for one year.
- Cyclophosphamide will be given orally once a day for 21 consecutive days and as stated
above will alternate with etoposide for one year.
- During the treatment, blood tests will be performed every three weeks except during the
first 3 week cycle in which testing is performed every 2 weeks. Appropriate imaging
studies will be performed every 9 weeks.
- The duration of treatment is one year unless the side effects are too harmful or the
tumor grows. Treatment may be continued past one year if the drugs are well tolerated
and disease progression has not occured.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To evaluate the feasibility of administering thalidomide, celecoxib, etoposide and cyclophosphamide for recurrent and poor prognosis tumors.
Mark W. Kieran, MD, PhD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|