NCT00073983

Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma (Closed to Accrual as of 12/21/06) or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma

Phase II Study Of Sequential Gemcitabine Followed By Docetaxel For Recurrent Ewing's Sarcoma, Osteosarcoma, Or Unresectable Or Locally Recurrent Chondrosarcoma [SARC Study]

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Sarcoma Alliance for Research through Collaboration · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

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 Ewing's sarcoma, or unresectable or locally recurrent chondrosarcoma.

Detailed description

OBJECTIVES: Primary * 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. 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 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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	filgrastim
BIOLOGICAL	pegfilgrastim	pegfilgrastim
DRUG	docetaxel	docetaxel
DRUG	gemcitabine hydrochloride	gemcitabine hydrochloride
GENETIC	microarray analysis	microarray analysis
OTHER	laboratory biomarker analysis	laboratory biomarker analysis
OTHER	pharmacokinetic study	pharmacokinetic study

Timeline

• Start date: 2006-10-01
• Primary completion: 2010-01-01
• Completion: 2010-12-01
• First posted: 2003-12-11
• Last updated: 2012-03-12
• Results posted: 2012-03-12