1 / 10

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.

darice
Télécharger la présentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related