Phase II Study Of Sequential Gemcitabine Followed By Docetaxel For Recurrent Ewing's Sarcoma, Osteosarcoma, Or Unresectable Or Locally Recurrent Chondrosarcoma [SARC Study]
- Determine the objective response rate in patients with recurrent osteosarcoma or
Ewing's sarcoma or unresectable or locally recurrent chondrosarcoma treated with
sequential gemcitabine and docetaxel.
- Determine the time to progression in patients treated with this regimen.
- Assess the toxicity of this regimen in these patients.
- Compare the pharmacokinetics of this regimen vs gemcitabine alone in these patients.
- Obtain tumor samples for cDNA microarray analysis of gene expression and development of
cell lines and xenotransplantation models.
OUTLINE: This is a nonrandomized, multicenter study.
Patients are stratified according to diagnosis recurrent osteosarcoma vs recurrent Ewing's
sarcoma vs unresectable or locally recurrent chondrosarcoma).
Patients receive gemcitabine intravenously over 90 minutes on days 1 and 8 and docetaxel
intravenously over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously
(SC) beginning on day 9 and continuing until blood counts recover. Patients may receive
pegfilgrastim SC on day 9 (once per course) as an alternative to G-CSF. Treatment repeats
every 21 days in the absence of disease progression or unacceptable toxicity.
Optional blood samples are collected at baseline and periodically during study for
pharmacokinetics studies. Optional tumor tissue samples from biopsy or surgical resection
are analysed for cDNA microarray analysis of gene expression.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
PROJECTED ACCRUAL: A maximum of 120 patients (40 per stratum) will be accrued for this study
within 17-24 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
Patients will be evaluated up to 4 time points(after 2,4,8 and 12 cycles of therapy), each cycle is 21 days. Per RECIST 1.0 and assessed by CT/MRI disease status will be categorized as R=CR/PR(response), F=progressive disease or death(failure), or S(stable disease=neither R nor F) based on the change from baseline. A patient with outcome R or F at any stage is scored as having that overall outcome, a patient with outcome S is re-evaluated after subsequent cycles of therapy. Patients who receive more than 14 cycles of therapy will be scored as the outcome at completion of cycle 14.
After 2, 4, 8 and 12 cycles of therapy, each cycle is 21 days
Shreyaskumar R. Patel, MD
Sarcoma Alliance for Research through Collaboration
United States: Institutional Review Board