Participant flow

Etoposide, Cyclophosphamide, Thalidomide, Celecoxib, and Fenofibrate in Relapsed or Progressive Cancer · Source last updated 2014-10-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: \< 20 kg at 100 mg; 20-50 kg at 200 mg; \> 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).

   id

   FG000

   title

   5-drug Metronomic Antiangiogenic Regimen

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         5

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         65

      type

      Progressive Disease

   4. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Not Started Protocol Therapy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         101

      type

      STARTED

   2. achievements

      1. comment

         4 pts did not start treatment due either to removal of consent or inability to get insurance.

         group Id

         FG000

         num Subjects

         97

      type

      Began Protocol Therapy

   3. achievements

      1. group Id

         FG000

         num Subjects

         24

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         77

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Patients must have recovered or stabalized the toxicity from prior therapy.

recruitment Details

The study was open for patient accrual at 11 different pediatric oncology centers from January 7, 2005 through March 6, 2009.

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Preserved source evidence · Not medical advice