Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073983
Status:
COMPLETED
Last Update Posted:
2012-03-12
First Post:
2003-12-10
Brief Title:
Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma Closed to Accrual as of 122106 or Ewings Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma
Sponsor:
Sarcoma Alliance for Research through Collaboration
Organization:
Sarcoma Alliance for Research through Collaboration
Study Overview
Official Title:
Phase II Study Of Sequential Gemcitabine Followed By Docetaxel For Recurrent Ewings Sarcoma Osteosarcoma Or Unresectable Or Locally Recurrent Chondrosarcoma SARC Study
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as gemcitabine and docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die Combining gemcitabine with docetaxel may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine with docetaxel in treating patients who have recurrent osteosarcoma recurrent Ewings sarcoma or unresectable or locally recurrent chondrosarcoma
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine with docetaxel in treating patients who have recurrent osteosarcoma recurrent Ewings sarcoma or unresectable or locally recurrent chondrosarcoma
Detailed Description:
OBJECTIVES
Primary
Determine the objective response rate in patients with recurrent osteosarcoma or Ewings sarcoma or unresectable or locally recurrent chondrosarcoma treated with sequential gemcitabine and docetaxel
Secondary
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 Ewings 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
Primary
Determine the objective response rate in patients with recurrent osteosarcoma or Ewings sarcoma or unresectable or locally recurrent chondrosarcoma treated with sequential gemcitabine and docetaxel
Secondary
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 Ewings 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None