drugset / Trial / NCT01313884

Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma

NCT01313884 ↗

Phase 2 Terminated 3 enrolled Stanford University Amgen · collab
NaSingle-groupOpen-labelTreatment

Summary

The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of care chemotherapy, with less than 30% survival. Based on recent encouraging pediatric literature we have designed this trial to improve the outcome of patients with metastatic Ewings sarcoma using Irinotecan and Temozolomide in addition to standard chemotherapy.

Timeline

Start
2011-05
Primary completion
2014-07
Completion
2014-07

Outcome

Outcome not reported

Stopped (Enrollment): “Study did not reach primary objective; study did not accrue enough patients.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 50 mg/m2 —
Subject Temozolomide Small molecule 100 mg/m2 —
Background Cyclophosphamide Other / unclassified 1200 mg/m2 —
Background Doxorubicin Other / unclassified 75 mg/m2 —
Background Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous
Background Vincristine Small molecule 2 mg/m2 —