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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Bone Cancer
Ewing's Sarcoma
Interventions: Drug: Irinotecan
Drug: Vincristine
Drug: Temozolomide
Drug: Doxorubicin
Drug: Cytoxan
Drug: Pegfilgrastim

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Combination Therapy

Regimen A alternate with Regimen B every 21 days

Regimen A:

Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)

Regimen B:

Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.

Irinotecan: 50 mg/m2/day x 5 days

Vincristine: 2 mg/m2 (capped at 2mg total do)

Temozolomide: 100 mg/m2/day x 5 days

Doxorubicin: 75 mg/m2

Cytoxan: 1200 mg/m2

Pegfilgrastim: 6 mg

Mesna: 240 mg/m2 in 50 ml NS


Participant Flow:   Overall Study
    Combination Therapy
STARTED   3 
COMPLETED   2 
NOT COMPLETED   1 
Per insurance pvdr, pt can't be on cl tr                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Combination Therapy

Regimen A alternate with Regimen B every 21 days

Regimen A:

Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)

Regimen B:

Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.

Irinotecan: 50 mg/m2/day x 5 days

Vincristine: 2 mg/m2 (capped at 2mg total do)

Temozolomide: 100 mg/m2/day x 5 days

Doxorubicin: 75 mg/m2

Cytoxan: 1200 mg/m2

Pegfilgrastim: 6 mg

Mesna: 240 mg/m2 in 50 ml NS


Baseline Measures
   Combination Therapy 
Overall Participants Analyzed 
[Units: Participants]
 3 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      3 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1  33.3% 
Male      2  66.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1  33.3% 
Not Hispanic or Latino      2  66.7% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1  33.3% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      1  33.3% 
More than one race      0   0.0% 
Unknown or Not Reported      1  33.3% 
Region of Enrollment 
[Units: Participants]
 
United States   3 


  Outcome Measures

1.  Primary:   Overall Response Rate (Partial and Complete Response)   [ Time Frame: Up to 24 months ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study did not reach primary objective; study didn't accrue enough patients.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kristen Ganjoo, MD
Organization: Stanford University Medical Center
phone: 650-725-6413
e-mail: kganjoo@stanford.edu



Responsible Party: Kristen Ganjoo, Stanford University
ClinicalTrials.gov Identifier: NCT01313884     History of Changes
Other Study ID Numbers: IRB-20323
SU-03082011-7559 ( Other Identifier: Stanford University )
SARCOMA0007 ( Other Identifier: OnCore )
First Submitted: March 10, 2011
First Posted: March 14, 2011
Results First Submitted: December 7, 2016
Results First Posted: February 2, 2017
Last Update Posted: November 24, 2017