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

Bone Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01313884
• Other study ID #: IRB-20323
• Secondary ID: SU-03082011-7559
• Status: Terminated
• Phase: Phase 2
• First received: March 10, 2011
• Last updated: October 20, 2017
• Start date: May 2011
• Est. completion date: July 2014

Study information

• Verified date: December 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Cancer
• Bone Neoplasms
• Ewing's Sarcoma
• Osteosarcoma
• Sarcoma
• Sarcoma, Ewing

Intervention

Drug:
• Irinotecan
50 mg/m2/day x 5 days
• Vincristine
2 mg/m2 to a maximum of 2 mg
• Temozolomide
100 mg/m2/day x 5 days followed by 2 weeks treatment-free
• Doxorubicin
Starting dose 75 mg/m2 to a maximum of 450mg/m2
• Cytoxan
1200 mg/m2
• Pegfilgrastim
6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (Partial and Complete Response)	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.	Up to 24 months
Secondary	Progression-free Survival (PFS)	The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment.	24 months