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Elizabeth Fox, NCI Pediatric Oncology Branch Shreyaskumar Patel, MD Anderson Cancer Center

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

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Elizabeth Fox, NCI Pediatric Oncology Branch Shreyaskumar Patel, MD Anderson Cancer Center

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  1. Phase II Study ofGemcitabine & Docetaxel in Recurrent Ewing’s Sarcoma, Osteosarcoma, or Unresectable/Locally Recurrent Chondrosarcoma SARC003 Elizabeth Fox, NCI Pediatric Oncology Branch Shreyaskumar Patel, MD Anderson Cancer Center

  2. Study Design • Primary Objective:Response Rate (RECIST) in OS, EWS, and Chondrosarcoma • Baysean Single Stage Design, efficacy and toxicity • Three Cohorts: OS, EWS, Chondrosarcoma • Response Rates of interest: • 35% OS • 35% EWS • 20% Chondrosarcoma • Early Stopping Rule for Response Rate < 5% • Maximum number of patients: 40/cohort

  3. Dose and Schedule DAY 1 DAY 8 DAY 9 Gemcitabine 675 mg/m2 IV over 90 min (7.5 mg/m2/min) • Cycle Duration 21 days • Maximum 14 cycles • Restaging Prior to C 1, 3, 5, 7*, 9, 13, and off study *pre-C7 restaging not used in statistical analysis Gemcitabine 675 mg/m2 IV over 90 min Docetaxel 75 mg/m2 IV over 60 min Filgrastim or Peg-filgrastim

  4. Patient Characteristics * Toxicity data complete for cycle 1

  5. Toxicity Cycle 1 (n= 32)

  6. Toxicity Subsequent Cycles (n=65 cycles)

  7. Patient Status PR (n=1) OS PR (n=1) EWS

  8. Interim Conclusions • Toxicity profile requires close monitoring • Hematological Toxicity (Gr 3/4) in 20% patients in Cycle 1 • Dose modifications required in 7 patients in subsequent cycles • Overall: 4 patients removed from study for toxicity 5 patients withdrew consent • Study Status • Osteosarcoma cohort Closed due to Inactivity • Ewing’s sarcoma and chondrosarcoma open to accrual • J Kyle Wathen, PhD to discuss statistical modeling pertinent to continued enrollment to EWS cohort

  9. Eligibility • Recurrent high grade OS, recurrent EWS, unresectable or locally recurrent unresectable chondrosarcoma • Age ≥ 4 years • Measurable Disease by RECIST Criteria • Prior Therapy: Recovered from toxicity (< grade 2) prior therapy ≤ 2 prior retrieval chemotherapy regimens (OS, EWS) • ≥ 2 weeks from myelosuppressive therapy • ≥ 6 months from myeloablative chemotherapy or TBI • ≥ 6 weeks local XRT, ≥ 4 months extensive XRT • ≥ 72 hr from last dose of filgrastim • Adequate Organ Function and Performance Status • Neuropathy ≤ grade 1(chemo); ≤ grade 2 (tumor/surgery) • No prior gemcitabine or taxane therapy or allergy • No prior allogeneic stem cell transplant

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