Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma
This study has been terminated.
(Study did not reach primary objective; study did not accrue enough patients.)
Information provided by (Responsible Party):
Kristen Ganjoo, Stanford University
First received: March 10, 2011
Last updated: December 7, 2016
Last verified: December 2016
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.
||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
||A Phase II Pilot Study of Cyclophosphamide, Doxorubicin, Vincristine Alternating With Irinotecan and Temozolomide in Patients With Newly Diagnosed Metastatic Ewing's Sarcoma
Primary Outcome Measures:
- 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 2 years 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.
Secondary Outcome Measures:
- Progression Free Survival [ Time Frame: 24 months ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
Experimental: Combination Therapy
Regimen A alternate with Regimen B every 21 days
Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)
Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.
50 mg/m2/day x 5 days
2 mg/m2 (capped at 2mg total do)
100 mg/m2/day x 5 days
Other Name: Neulasta
240 mg/m2 in 50 ml NS
|Ages Eligible for Study:
||13 Years and older (Child, Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313884
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
||Kristen N. Ganjoo
||Kristen Ganjoo, Assistant Professor of Medicine, Stanford University
History of Changes
|Other Study ID Numbers:
SU-03082011-7559 ( Other Identifier: Stanford University )
SARCOMA0007 ( Other Identifier: OnCore )
|Study First Received:
||March 10, 2011
|Results First Received:
||December 7, 2016
||December 7, 2016
|Individual Participant Data (IPD) Sharing Statement:
|Plan to Share IPD:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 21, 2017
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms by Site
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action