Study on VCD/IE in the Patients With ESFT (Ewing's Sarcoma Family of Tumors) - Full Text View

Sponsored by:	Fudan University
Information provided by:	Fudan University
ClinicalTrials.gov Identifier:	NCT00568464

Purpose

The purpose of this clinical trial was to evaluate the efficacy and tolerability of the sequential therapy of VCD/IE in the patients with ESFT.

Condition	Intervention	Phase
Ewing's Sarcoma	Drug: VCR,CTX,ADM;IFO,VP-16	Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Mesna Etoposide Granulocyte colony-stimulating factor Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of VCD/IE in the Treatment of the Patients With Ewing's Sarcoma Family of Tumors

Further study details as provided by Fudan University:

Primary Outcome Measures:

Response Rate [ Time Frame: every two cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	March 2007
Estimated Study Completion Date:	September 2009

Arms	Assigned Interventions
A: Experimental	Drug: VCR,CTX,ADM;IFO,VP-16 VCD:VCR 2mg d1,CTX 1200mg/m2 d1,Mesna 240mg/m2 tid d1,ADM 75mg/m2 d1,G-CSF 300ug/d d5-11;IE:IFO 1800mg/m2 d1-5,Mesna 360mg/m2 tid d1-5,VP-16 100mg/m2 d1-5,G-CSF 300ug/d d6-12;q3w.Surgery or radiation will be done to the patients with local diseases after four cycles of VCD/IE.

Detailed Description:

80-90% patients of ESFT will develope disease progression during the period of local treatment (surgery or radiation).The survival has been improved in these 30 years due to chemotherapy.VCD/IE is widely used in the world for the patients with ESFT,but it is rarely used in China due to its high dosage.

Eligibility

Ages Eligible for Study:	10 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age range 10-65 years old
Histological confirmed ESFT
No previous therapy
ECOG performance status less than 2
Life expectancy of more than 12 weeks
Normal laboratory values: hemoglobin>8.0g/dl, neutrophil>2×109/L, platelet>80×109/L,Hb>80×1012/L,serum creatine<1×upper limitation of normal(ULN),serum bilirubin<1.5×ULN,ALT and AST<2.5×ULN

Exclusion Criteria:

Pregnant or lactating women
Received treatment for the disease previously
Serious uncontrolled diseases and intercurrent infection
The evidence of CNS metastasis and bone marrow involvement
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
History of allergy to the drugs in this trial
Abnormal LVEF level.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568464

Contacts

Contact: Ye Guo, M.D.

8613501678472

pattrick_guo@msn.com

Locations

China
Fudan University Cancer Hospital	Recruiting
Shanghai, China, 200032
Contact: Haiyi Guo, MD 8613818068164
Principal Investigator: Ye Guo, M.D.

Sponsors and Collaborators

Fudan University

Investigators

Principal Investigator:

Ye Guo, M.D.

Fudan University Cancer Hospital

More Information

Responsible Party:	Fudan University cancer hospital ( Base for drug clinical trials, Fudan University cancer hospital )
Study ID Numbers:	VCD/IE-ESFT
Study First Received:	December 5, 2007
Last Updated:	December 10, 2007
ClinicalTrials.gov Identifier:	NCT00568464
Health Authority:	China: Ethics Committee

Keywords provided by Fudan University:

ESFT(Ewing's sarcoma family of tumors)
Response rate
TTP
OS
Toxicity

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Sarcoma, Ewing's
Ewing's family of tumors
Malignant mesenchymal tumor
Sarcoma

Osteosarcoma
Mesna
Etoposide phosphate
Etoposide
Osteogenic sarcoma
Soft tissue sarcomas

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 15, 2009