1. SARC003: Phase II Study of Gemcitabine & Docetaxel in Recurrent Ewings Sarcoma, Osteosarcoma, or Unresectable/Locally Recurrent Chondrosarcoma
Elizabeth Fox, NCI Pediatric Oncology Branch
Shreyaskumar Patel, MD Anderson Cancer Center

2. 675 mg/m2 IV over 90 min (7.5 mg/m2/min)
Dose and Schedule
DAY 1
DAY 8
DAY 9
Gemcitabine
675 mg/m2 IV over 90 min (7.5 mg/m2/min)
Docetaxel
75 mg/m2 IV over 60 min
Gemcitabine
675 mg/m2 IV over 90 min
Filgrastim
or Pegfilgrastim
Cycle Duration 21 days
Restaging prior to cycles 1, 3, 5, 7, 9, 13, 15,
then every 4th cycle and off study
Target Response rate:
OS: 35%
EWS: 35%
Chondrosarcoma: 20%

3. Patient Characteristics
Enrolled/Evaluable:
42/42
Median Age (range):
36.3y ( y)
Number ≤ 21 yrs 5
Male:Female
24:18
Osteosarcoma 14
Ewings Sarcoma
Chondrosarcoma

4. Toxicity (Cycle 1)

5. Toxicity (Cycle 2+, n=86 cycles)
Seven patients (17%) have discontinued therapy due to toxicity
Five patients (12%) withdrew consent

6. Response (RECIST) Cohort Off Study # Cycles Median (range) On Study
Best Response OS
(n=14) 14
2 (1-14+)
Closed
1 PR
EWS
2 (1-12)
none
2 PR
Chondro 13
2 (1-10+)
1 (C10+)
None confirmed

7. Response in EWS
Baseline
Prior to C9
Prior to C12

8. Interim Conclusions
Toxicity, particularly hematological toxicity, requires close monitoring.
Pharmacokinetic samples collected on 23 patients (49%), batched for analysis.
Trial Status
Osteosarcoma cohort closed due to inactivity.
Accrual to EWS and Chondrosarcoma cohorts ongoing.
2 PR’s in EWS cohort
Protocol Amendment F distributed 5/18/2007
Remove maximum number of cycles
Update toxicities in consent