Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma
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|ClinicalTrials.gov Identifier: NCT01313884|
Recruitment Status : Terminated (Study did not reach primary objective; study did not accrue enough patients.)
First Posted : March 14, 2011
Results First Posted : February 2, 2017
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bone Cancer Ewing's Sarcoma||Drug: Irinotecan Drug: Vincristine Drug: Temozolomide Drug: Doxorubicin Drug: Cytoxan Drug: Pegfilgrastim||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Pilot Study of Cyclophosphamide, Doxorubicin, Vincristine Alternating With Irinotecan and Temozolomide in Patients With Newly Diagnosed Metastatic Ewing's Sarcoma|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Combination Therapy
Regimen A alternating with Regimen B every 21 days
50 mg/m2/day x 5 days
Other Names:Drug: Vincristine
2 mg/m2 to a maximum of 2 mg
Other Names:Drug: Temozolomide
100 mg/m2/day x 5 days followed by 2 weeks treatment-free
Other Names:Drug: Doxorubicin
Starting dose 75 mg/m2 to a maximum of 450mg/m2
Other Names:Drug: Cytoxan
Other Names:Drug: Pegfilgrastim
6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle
Other Name: Neulasta
- Overall Response Rate (Partial and Complete Response) [ Time Frame: Up to 24 months ]
Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for up to 2 years (24 months) or until progression of disease or initiation of new anticancer therapy.
Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters.
- Progression-free Survival (PFS) [ Time Frame: 24 months ]The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313884
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Kristen N. Ganjoo||Stanford University|