1 / 8

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

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. Dose and Schedule. DAY 1. DAY 8. DAY 9. Gemcitabine

matteo
Download Presentation

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. 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. 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

  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)

  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

More Related