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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionBone Cancer
Ewing's Sarcoma
InterventionDrug: Irinotecan
Drug: Vincristine
Drug: Temozolomide
Drug: Doxorubicin
Drug: Cytoxan
Drug: Pegfilgrastim
Drug: Mesna
PhasePhase 2
SponsorStanford University
Responsible PartyStanford University
ClinicalTrials.gov IdentifierNCT01313884
First ReceivedMarch 10, 2011
Last UpdatedJanuary 10, 2014
Last verifiedJanuary 2014

Tracking Information[ + expand ][ + ]

First Received DateMarch 10, 2011
Last Updated DateJanuary 10, 2014
Start DateMay 2011
Estimated Primary Completion DateJune 2016
Current Primary Outcome MeasuresOverall Response Rate (Partial and Complete Response) [Time Frame: 24 months] [Designated as safety issue: No]
Current Secondary Outcome Measuresprogression free survival [Time Frame: 24 months] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleCyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma
Official TitleA Phase II Pilot Study of Cyclophosphamide, Doxorubicin, Vincristine Alternating With Irinotecan and Temozolomide in Patients With Newly Diagnosed Metastatic Ewing's Sarcoma
Brief 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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Bone Cancer
  • Ewing's Sarcoma
InterventionDrug: Irinotecan
50 mg/m2/day x 5 days
Other Names:
  • Camptosar
  • Campto
Drug: Vincristine
2 mg/m2 (capped at 2mg total do)
Other Names:
  • Oncovin
  • leurocristine
Drug: Temozolomide
100 mg/m2/day x 5 days
Other Names:
  • Temodar
  • Temodal
Drug: Doxorubicin
75 mg/m2
Other Names:
  • Adriamycin
  • hydroxydaunorubicin
Drug: Cytoxan
1200 mg/m2
Other Names:
  • Cyclophosphamide
  • Endoxan
  • Neosar
  • Procytox
  • Revimmune
  • cytophosphane
Drug: Pegfilgrastim
6 mg
Other Names:
NeulastaDrug: Mesna
240 mg/m2 in 50 ml NS
Other Names:
  • Uromitexan
  • Mesnex
Study Arm (s)Experimental: 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.

Recruitment Information[ + expand ][ + ]

Recruitment StatusActive, not recruiting
Estimated Enrollment20
Estimated Completion DateJune 2016
Estimated Primary Completion DateJune 2014
Eligibility Criteria
Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of metastatic Ewing's sarcoma.

- Patients must have measurable disease defined as lesions that can be measured by
medical imaging techniques such as CT or MRI. Ascites, pleural fluid, bone marrow
disease, lesions seen on scan will not be considered measurable.

- Patients must have metastatic disease.

- Age 13 years or older

- Life expectancy of at least 3 months.

- ECOG performance status of <= 3.

- Normal hepatic function (Direct bilirubin <1.5mg/dl, SGOT or SGPT <3x upper limit of
normal).

- Left Ventricular Ejection fraction of at least 50%.

- Adequate renal function: Creatinine clearance >= 50 ml/min or Serum creatinine < 1.5
x ULN for age.

- Adequate bone marrow reserve (defined as an absolute peripheral granulocyte count of
>=1500/mm3, platelet count of >=75,000/mm3); unless bone marrow infiltrated with
metastatic Ewing's sarcoma; ANC >= 500 and Platelet >= 50,000 mm3.

- Ability to understand and willing to sign a written informed consent document.

- Patients of childbearing potential must agree to use an effective method of
contraception.

Exclusion Criteria:

- No prior chemotherapy for Ewing's sarcoma; No prior doxorubicin, temozolomide or
irinotecan.

- Known hypersensitivity to any of the components of the protocol drugs.

- Clinically significant unrelated systemic illness (such as serious infections
requiring active systemic intravenous antibiotic therapy; cardiovascular disease
[congestive heart failure, recent myocardial infarction, unstable angina,
inadequately controlled hypertension].

- No prior history of chronic diarrhea, bowel obstruction, Crohn's disease or
ulcerative colitis.

- Pregnant or nursing woman are not included in the study.

- HIV-positive patients will be excluded from the study due to risk of infection or
other serious side effects.

- Other medical, psychiatric or social condition incompatible with study treatment.
GenderBoth
Ages13 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01313884
Other Study ID NumbersSARCOMA0007
Has Data Monitoring CommitteeYes
Information Provided ByStanford University
Study SponsorStanford University
CollaboratorsAmgen
Investigators Principal Investigator: Kristen N. Ganjoo Stanford University
Verification DateJanuary 2014

Locations[ + expand ][ + ]

Stanford University School of Medicine
Stanford, California, United States, 94305